Evaluating the safety of Administration of Adenosine, Lidocaine, and Mg(ALM) cocktail among Multiple Trauma Patients receiving Massive Transfusion with dose escalation A phase I, clinical trial
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Protocol summary
The cocktail will be started in a group of 4 patients. if safety is confirmed the dose will be increased in next three patients.The ALM combination will be administered as the bolus and maintenance IV fluid. The maximom bolus dose of ALM IV injection consists of 200cc of 3% hypertonic saline,(87mg) of 2% Lidocaine, (6 mg) of adenosine and (30mg) of magnesium sulfate .The maximum dose of drip combination consists of 0.16 mg/kg/hr lidocaine, 0.19 mg/kg/hr Adenosine, and 0.2 mg/kg/hr MgSO4.Every drip component should be injected from separate bottle in 300 cc normal saline .
The cocktail will be started in a group of 4 patients. if safety is confirmed the dose will be increased in next three patients.The ALM combination will be administered as the bolus and maintenance IV fluid. The maximom bolus dose of ALM IV injection consists of 200cc of normal saline,(87mg) of 2% Lidocaine, (6 mg) of adenosine and (30mg) of magnesium sulfate .The maximum dose of drip combination consists of 0.16 mg/kg/hr lidocaine, 0.19 mg/kg/hr Adenosine, and 0.2 mg/kg/hr MgSO4.Every drip component should be injected from separate bottle in 300 cc normal saline .
The cocktail will be started in a group of 4 patients. if safety is confirmed the dose will be increased in next three patients.The ALM combination will be administered as the bolus and maintenance IV fluid. The maximom bolus dose of ALM IV injection consists of 200cc of 3% hypertonicnormal saline,(87mg) of 2% Lidocaine, (6 mg) of adenosine and (30mg) of magnesium sulfate .The maximum dose of drip combination consists of 0.16 mg/kg/hr lidocaine, 0.19 mg/kg/hr Adenosine, and 0.2 mg/kg/hr MgSO4.Every drip component should be injected from separate bottle in 300 cc normal saline .
ابتدا از کمترین دوز کوکتل در تعداد 4 نفر شروع میشود سپس در صورت امنیت دارو در 3 نفر بعد دوز دارو افزایش می یابد.کوکتل شامل آدنوزین لیدوکائین منیزیم در یک دوز بلوس و یک دوز نگهدارنده از راه داخل وریدی تزریق میشود . حداکثر دوز بلوز شامل ۲۰۰ سی سی سالین هایپرتونیک ، ۸۷ میلی‌گرم لیدوکائین ۲ درصد, ۶ میلی‌گرم آدنوزین و ۳۰ میلی‌گرم از منیزیم سولفات میباشد. حداکثر دوز نگهدارنده شامل ۰.۱۶ میلی گرم/کیلوگرم/ساعت لیدوکایین، ۰.۱۹ میلی گرم/کیلوگرم/ساعت آدنوزین و ۰.۲ میلی گرم/کیلوگرم/ساعت منیزیم سولفات میباشد. دوز نگهدارنده هر دارو باید از بطری جداگانه با ۳۰۰ سی سی نرمال سالین تزریق شود.
ابتدا از کمترین دوز کوکتل در تعداد 4 نفر شروع میشود سپس در صورت امنیت دارو در 3 نفر بعد دوز دارو افزایش می یابد.کوکتل شامل آدنوزین لیدوکائین منیزیم در یک دوز بلوس و یک دوز نگهدارنده از راه داخل وریدی تزریق میشود . حداکثر دوز بلوز شامل ۲۰۰ سی سی سالین نرمال ، ۸۷ میلی‌گرم لیدوکائین ۲ درصد, ۶ میلی‌گرم آدنوزین و ۳۰ میلی‌گرم از منیزیم سولفات میباشد. حداکثر دوز نگهدارنده شامل ۰.۱۶ میلی گرم/کیلوگرم/ساعت لیدوکایین، ۰.۱۹ میلی گرم/کیلوگرم/ساعت آدنوزین و ۰.۲ میلی گرم/کیلوگرم/ساعت منیزیم سولفات میباشد. دوز نگهدارنده هر دارو باید از بطری جداگانه با ۳۰۰ سی سی نرمال سالین تزریق شود.
ابتدا از کمترین دوز کوکتل در تعداد 4 نفر شروع میشود سپس در صورت امنیت دارو در 3 نفر بعد دوز دارو افزایش می یابد.کوکتل شامل آدنوزین لیدوکائین منیزیم در یک دوز بلوس و یک دوز نگهدارنده از راه داخل وریدی تزریق میشود . حداکثر دوز بلوز شامل ۲۰۰ سی سی سالین هایپرتونیکنرمال ، ۸۷ میلی‌گرم لیدوکائین ۲ درصد, ۶ میلی‌گرم آدنوزین و ۳۰ میلی‌گرم از منیزیم سولفات میباشد. حداکثر دوز نگهدارنده شامل ۰.۱۶ میلی گرم/کیلوگرم/ساعت لیدوکایین، ۰.۱۹ میلی گرم/کیلوگرم/ساعت آدنوزین و ۰.۲ میلی گرم/کیلوگرم/ساعت منیزیم سولفات میباشد. دوز نگهدارنده هر دارو باید از بطری جداگانه با ۳۰۰ سی سی نرمال سالین تزریق شود.
General information
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Due to the fact that the patients in the recovery room of the hospital usually receive up to 2 packs of blood and if needed, the rest of the blood is done in the inpatient departments or after transfer for better monitoring of the patients in the recovery room the criteria for inclusion in the study was changed instead of starting from the third pack to the second pack. Also, due to the lack of hypertonic saline, 3% of normal saline will be used in the blous dose.
Due to the fact that the patients in the recovery room of the hospital usually receive up to 2 packs of blood and if needed, the rest of the blood is done in the inpatient departments or after transfer for better monitoring of the patients in the recovery room the criteria for inclusion in the study was changed instead of starting from the third pack to the second pack. Also, due to the lack of hypertonic saline, 3% of normal saline will be used in the blous dose.
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به دلیل این که بیماران اتاق احیای بیمارستان معمولا تا ۲ پک خون دریافت می کنند و در صورت نیاز بقیه خون در بخش های بستری یا پس از ترانسفر انجام می شود برای تحت نظر بودن بهتر بیماران در اتاق احیا مطالعه به جای شروع از سومین پک به دومین پک تغییر داده شد همینطور در دوز بلوس به دلیل نبود سالین هایپر تونیک ۳درصد از نرمال سالین استفاده خواهد شد
به دلیل این که بیماران اتاق احیای بیمارستان معمولا تا ۲ پک خون دریافت می کنند و در صورت نیاز بقیه خون در بخش های بستری یا پس از ترانسفر انجام می شود برای تحت نظر بودن بهتر بیماران در اتاق احیا مطالعه به جای شروع از سومین پک به دومین پک تغییر داده شد همینطور در دوز بلوس به دلیل نبود سالین هایپر تونیک ۳درصد از نرمال سالین استفاده خواهد شد
بررسی ایمنی مصرف کوکتل ، لیدوکائین و منیزیم در بیماران با ترومای متعدد دریافت کننده ماسیو ترانسفیوژن با افزایش تدریجی دوز : مطالعه کارآزمایی فاز اول
بررسی ایمنی مصرف کوکتل آدنوزین ، لیدوکائین و منیزیم در بیماران با ترومای متعدد دریافت کننده ماسیو ترانسفیوژن با افزایش تدریجی دوز : مطالعه کارآزمایی فاز اول
بررسی ایمنی مصرف کوکتل آدنوزین ، لیدوکائین و منیزیم در بیماران با ترومای متعدد دریافت کننده ماسیو ترانسفیوژن با افزایش تدریجی دوز : مطالعه کارآزمایی فاز اول
Injury severity score more than 16
Systlic blood presure less than 70 or Systolic blood pressure less than 90 and heart rate more than 108
Candidate to recieve the third pack of packed red blood cell
Injury severity score more than 16
Systlic blood presure less than 70 or Systolic blood pressure less than 90 and heart rate more than 108
Candidate to recieve the second pack of packed red blood cell
Injury severity score more than 16 Systlic blood presure less than 70 or Systolic blood pressure less than 90 and heart rate more than 108 Candidate to recieve the thirdsecond pack of packed red blood cell
نمره شدت جراحت بیشتر از ۱۶
فشار سیستول کمتر از ۷۰ یا فشار سیستول کمتر از ۷۰ و ضربان قلب بیش از ۱۰۸
کاندیدای دریافت کیسه سوم گلبول قرمز فشرده
نمره شدت جراحت بیشتر از ۱۶
فشار سیستول کمتر از ۷۰ یا فشار سیستول کمتر از ۷۰ و ضربان قلب بیش از ۱۰۸
کاندیدای دریافت کیسه دوم گلبول قرمز فشرده
نمره شدت جراحت بیشتر از ۱۶ فشار سیستول کمتر از ۷۰ یا فشار سیستول کمتر از ۷۰ و ضربان قلب بیش از ۱۰۸ کاندیدای دریافت کیسه سومدوم گلبول قرمز فشرده
Intervention groups
#1
1st Intervention group: Adenosine lidocaine magnesium combination will be given to 4 eligible patients simultaneously with the third blood bag in two doses of bolus and infusion. If the safety of the cocktail is confirmed by the decision of the research team in the next group, the dose of the drug will be increased in next group. The cocktail dosage in first 4 patienst is as follows: the bolus dose consists of 200 cc of 3% hypertonic saline, 4 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 20 mg of lidocaine, 30 mg of magnesium sulfate. These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.08 mg/kg/hour lidocaine, 0.09 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
1st Intervention group: Adenosine lidocaine magnesium combination will be given to 4 eligible patients simultaneously with the second blood bag in two doses of bolus and infusion. If the safety of the cocktail is confirmed by the decision of the research team in the next group, the dose of the drug will be increased in next group. The cocktail dosage in first 4 patienst is as follows: the bolus dose consists of 200 cc of normal saline, 4 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 20 mg of lidocaine, 30 mg of magnesium sulfate. These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.08 mg/kg/hour lidocaine, 0.09 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
1st Intervention group: Adenosine lidocaine magnesium combination will be given to 4 eligible patients simultaneously with the thirdsecond blood bag in two doses of bolus and infusion. If the safety of the cocktail is confirmed by the decision of the research team in the next group, the dose of the drug will be increased in next group. The cocktail dosage in first 4 patienst is as follows: the bolus dose consists of 200 cc of 3% hypertonicnormal saline, 4 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 20 mg of lidocaine, 30 mg of magnesium sulfate. These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.08 mg/kg/hour lidocaine, 0.09 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
گروه مداخله اول :به ۴ نفر از بیماران واجد شرایط ترکیب آدنوزین لیدوکائین منیزیم همزمان با سومین کیسه خون دریافتی در دو دوز بلوس و اینفیوژن داده خواهد شد در صورت تایید امنیت دارو با تصمیم تیم اجرا کننده تحقیق در گروه بعد دوز دارو افزایش خواهد یافت میزان دوز دارو در 4 نفر اول به این شرح است: در دوز بلوس ۲۰۰ سی سی سالین هایپرتونیک ۳ درصد، ۴ میلی‌گرم آدنوزین(تزریق در یک تا دو ثانیه همراه با ۲۰ سی سی نرمال سالین)، ۲۰ میلی‌گرم لیدوکائین ۳۰ میلی‌گرم منیزیم سولفات داده خواهد شد. این ترکیبات جداگانه تزریق خواهد شد.پس از تزریق دوز بلوس دوز اینفیوژن طی ۴ ساعت تزریق خواهد شد. دوز اینفیوژن شامل 0.08 میلی گرم/ کیلوگرم/ساعت لیدوکائین ، 0.09 میلی گرم/ کیلوگرم/ساعت آدنوزین و 0.2 میلی گرم/ کیلوگرم/ساعت منیزیم خواهد بود. هر کدام از این داروها در ۳۰۰ سی سی نرمال سالین تزریق خواهد شد.
گروه مداخله اول :به ۴ نفر از بیماران واجد شرایط ترکیب آدنوزین لیدوکائین منیزیم همزمان با دومین کیسه خون دریافتی در دو دوز بلوس و اینفیوژن داده خواهد شد در صورت تایید امنیت دارو با تصمیم تیم اجرا کننده تحقیق در گروه بعد دوز دارو افزایش خواهد یافت میزان دوز دارو در 4 نفر اول به این شرح است: در دوز بلوس ۲۰۰ سی سی سالین نرمال ، ۴ میلی‌گرم آدنوزین(تزریق در یک تا دو ثانیه همراه با ۲۰ سی سی نرمال سالین)، ۲۰ میلی‌گرم لیدوکائین ۳۰ میلی‌گرم منیزیم سولفات داده خواهد شد. این ترکیبات جداگانه تزریق خواهد شد.پس از تزریق دوز بلوس دوز اینفیوژن طی ۴ ساعت تزریق خواهد شد. دوز اینفیوژن شامل 0.08 میلی گرم/ کیلوگرم/ساعت لیدوکائین ، 0.09 میلی گرم/ کیلوگرم/ساعت آدنوزین و 0.2 میلی گرم/ کیلوگرم/ساعت منیزیم خواهد بود. هر کدام از این داروها در ۳۰۰ سی سی نرمال سالین تزریق خواهد شد.
گروه مداخله اول :به ۴ نفر از بیماران واجد شرایط ترکیب آدنوزین لیدوکائین منیزیم همزمان با سومیندومین کیسه خون دریافتی در دو دوز بلوس و اینفیوژن داده خواهد شد در صورت تایید امنیت دارو با تصمیم تیم اجرا کننده تحقیق در گروه بعد دوز دارو افزایش خواهد یافت میزان دوز دارو در 4 نفر اول به این شرح است: در دوز بلوس ۲۰۰ سی سی سالین هایپرتونیک ۳ درصدنرمال ، ۴ میلی‌گرم آدنوزین(تزریق در یک تا دو ثانیه همراه با ۲۰ سی سی نرمال سالین)، ۲۰ میلی‌گرم لیدوکائین ۳۰ میلی‌گرم منیزیم سولفات داده خواهد شد. این ترکیبات جداگانه تزریق خواهد شد.پس از تزریق دوز بلوس دوز اینفیوژن طی ۴ ساعت تزریق خواهد شد. دوز اینفیوژن شامل 0.08 میلی گرم/ کیلوگرم/ساعت لیدوکائین ، 0.09 میلی گرم/ کیلوگرم/ساعت آدنوزین و 0.2 میلی گرم/ کیلوگرم/ساعت منیزیم خواهد بود. هر کدام از این داروها در ۳۰۰ سی سی نرمال سالین تزریق خواهد شد.
#2
2end Intervention group: If the safety of the drug is confirmed in the previous stage, in this stage the dosage of the drugs will be slightly increased with the same implementation method as the previous group, which this time will be done on 5 patients. The cocktail dosage in this group is as follows: the bolus dose consists of 200 cc of 3% hypertonic saline, 6 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 40 mg of lidocaine, 30 mg of magnesium sulfate(Magnesium sulfate calculated by the clinical pharmacologist is much lower than the minimum effective dose in the clinic, so it does not need to gradually increase the dose). These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.1 mg/kg/hour lidocaine, 0.12 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
2end Intervention group: If the safety of the drug is confirmed in the previous stage, in this stage the dosage of the drugs will be slightly increased with the same implementation method as the previous group, which this time will be done on 5 patients. The cocktail dosage in this group is as follows: the bolus dose consists of 200 cc of normal saline, 6 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 40 mg of lidocaine, 30 mg of magnesium sulfate(Magnesium sulfate calculated by the clinical pharmacologist is much lower than the minimum effective dose in the clinic, so it does not need to gradually increase the dose). These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.1 mg/kg/hour lidocaine, 0.12 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
2end Intervention group: If the safety of the drug is confirmed in the previous stage, in this stage the dosage of the drugs will be slightly increased with the same implementation method as the previous group, which this time will be done on 5 patients. The cocktail dosage in this group is as follows: the bolus dose consists of 200 cc of 3% hypertonicnormal saline, 6 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 40 mg of lidocaine, 30 mg of magnesium sulfate(Magnesium sulfate calculated by the clinical pharmacologist is much lower than the minimum effective dose in the clinic, so it does not need to gradually increase the dose). These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.1 mg/kg/hour lidocaine, 0.12 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
گروه مداخله دوم :در صورت تایید ایمنی دارو در مرحله قبل در این مرحله دوز داروها کمی افزایش خواهد یافت با روش اجرای مشابه با گروه قبل که این بار روی ۵ نفر انجام خواهد شد. میزان دوز دارو در این گروه به این شرح است: در دوز بلوس ۲۰۰ سی سی سالین هایپرتونیک ۳ درصد، 6 میلی‌گرم آدنوزین(تزریق در یک تا دو ثانیه همراه با ۲۰ سی سی نرمال سالین)، 40 میلی‌گرم لیدوکائین ۳۰ میلی‌گرم منیزیم سولفات (منیزیم سولفات در دوز حساب شده توسط فارماکولوژیست بسیار پایین‌تر از حداقل دوز معمول در کلینیک است بنابراین نیاز به افزایش دوز تدریجی ندارد) داده خواهد شد. این ترکیبات جداگانه تزریق خواهد شد.پس از تزریق دوز بلوس دوز اینفیوژن طی ۴ ساعت تزریق خواهد شد. دوز اینفیوژن شامل 0.1 میلی گرم/ کیلوگرم/ساعت لیدوکائین ، 0.12 میلی گرم/ کیلوگرم/ساعت آدنوزین و 0.2 میلی گرم/ کیلوگرم/ساعت منیزیم خواهد بود. هر کدام از این داروها در ۳۰۰ سی سی نرمال سالین تزریق خواهد شد.
گروه مداخله دوم :در صورت تایید ایمنی دارو در مرحله قبل در این مرحله دوز داروها کمی افزایش خواهد یافت با روش اجرای مشابه با گروه قبل که این بار روی ۵ نفر انجام خواهد شد. میزان دوز دارو در این گروه به این شرح است: در دوز بلوس ۲۰۰ سی سی سالین نرمال، 6 میلی‌گرم آدنوزین(تزریق در یک تا دو ثانیه همراه با ۲۰ سی سی نرمال سالین)، 40 میلی‌گرم لیدوکائین ۳۰ میلی‌گرم منیزیم سولفات (منیزیم سولفات در دوز حساب شده توسط فارماکولوژیست بسیار پایین‌تر از حداقل دوز معمول در کلینیک است بنابراین نیاز به افزایش دوز تدریجی ندارد) داده خواهد شد. این ترکیبات جداگانه تزریق خواهد شد.پس از تزریق دوز بلوس دوز اینفیوژن طی ۴ ساعت تزریق خواهد شد. دوز اینفیوژن شامل 0.1 میلی گرم/ کیلوگرم/ساعت لیدوکائین ، 0.12 میلی گرم/ کیلوگرم/ساعت آدنوزین و 0.2 میلی گرم/ کیلوگرم/ساعت منیزیم خواهد بود. هر کدام از این داروها در ۳۰۰ سی سی نرمال سالین تزریق خواهد شد.
گروه مداخله دوم :در صورت تایید ایمنی دارو در مرحله قبل در این مرحله دوز داروها کمی افزایش خواهد یافت با روش اجرای مشابه با گروه قبل که این بار روی ۵ نفر انجام خواهد شد. میزان دوز دارو در این گروه به این شرح است: در دوز بلوس ۲۰۰ سی سی سالین هایپرتونیک ۳ درصدنرمال، 6 میلی‌گرم آدنوزین(تزریق در یک تا دو ثانیه همراه با ۲۰ سی سی نرمال سالین)، 40 میلی‌گرم لیدوکائین ۳۰ میلی‌گرم منیزیم سولفات (منیزیم سولفات در دوز حساب شده توسط فارماکولوژیست بسیار پایین‌تر از حداقل دوز معمول در کلینیک است بنابراین نیاز به افزایش دوز تدریجی ندارد) داده خواهد شد. این ترکیبات جداگانه تزریق خواهد شد.پس از تزریق دوز بلوس دوز اینفیوژن طی ۴ ساعت تزریق خواهد شد. دوز اینفیوژن شامل 0.1 میلی گرم/ کیلوگرم/ساعت لیدوکائین ، 0.12 میلی گرم/ کیلوگرم/ساعت آدنوزین و 0.2 میلی گرم/ کیلوگرم/ساعت منیزیم خواهد بود. هر کدام از این داروها در ۳۰۰ سی سی نرمال سالین تزریق خواهد شد.
#3
3rd Intervention group: If the safety of the drug is confirmed in the previous stage, in this stage the dosage of the drugs will be slightly increased with the same implementation method as the previous group, which this time will be done on 4 patients. The cocktail dosage in this group is as follows: the bolus dose consists of 200 cc of 3% hypertonic saline, 9 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 60 mg of lidocaine, 30 mg of magnesium sulfate(Magnesium sulfate calculated by the clinical pharmacologist is much lower than the minimum effective dose in the clinic, so it does not need to gradually increase the dose). These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.13 mg/kg/hour lidocaine, 0.14 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
3rd Intervention group: If the safety of the drug is confirmed in the previous stage, in this stage the dosage of the drugs will be slightly increased with the same implementation method as the previous group, which this time will be done on 4 patients. The cocktail dosage in this group is as follows: the bolus dose consists of 200 cc of normal saline, 9 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 60 mg of lidocaine, 30 mg of magnesium sulfate(Magnesium sulfate calculated by the clinical pharmacologist is much lower than the minimum effective dose in the clinic, so it does not need to gradually increase the dose). These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.13 mg/kg/hour lidocaine, 0.14 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
3rd Intervention group: If the safety of the drug is confirmed in the previous stage, in this stage the dosage of the drugs will be slightly increased with the same implementation method as the previous group, which this time will be done on 4 patients. The cocktail dosage in this group is as follows: the bolus dose consists of 200 cc of 3% hypertonicnormal saline, 9 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 60 mg of lidocaine, 30 mg of magnesium sulfate(Magnesium sulfate calculated by the clinical pharmacologist is much lower than the minimum effective dose in the clinic, so it does not need to gradually increase the dose). These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.13 mg/kg/hour lidocaine, 0.14 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
#4
4th Intervention group: If the safety of the drug is confirmed in the previous stage, in this stage the dosage of the drugs will be slightly increased with the same implementation method as the previous group, which this time will be done on 4 patients. The cocktail dosage in this group is as follows: the bolus dose consists of 200 cc of 3% hypertonic saline, 12 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 87 mg of lidocaine, 30 mg of magnesium sulfate(Magnesium sulfate calculated by the clinical pharmacologist is much lower than the minimum effective dose in the clinic, so it does not need to gradually increase the dose). These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.16 mg/kg/hour lidocaine, 0.16 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
4th Intervention group: If the safety of the drug is confirmed in the previous stage, in this stage the dosage of the drugs will be slightly increased with the same implementation method as the previous group, which this time will be done on 4 patients. The cocktail dosage in this group is as follows: the bolus dose consists of 200 cc of normal saline, 12 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 87 mg of lidocaine, 30 mg of magnesium sulfate(Magnesium sulfate calculated by the clinical pharmacologist is much lower than the minimum effective dose in the clinic, so it does not need to gradually increase the dose). These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.16 mg/kg/hour lidocaine, 0.16 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
4th Intervention group: If the safety of the drug is confirmed in the previous stage, in this stage the dosage of the drugs will be slightly increased with the same implementation method as the previous group, which this time will be done on 4 patients. The cocktail dosage in this group is as follows: the bolus dose consists of 200 cc of 3% hypertonicnormal saline, 12 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 87 mg of lidocaine, 30 mg of magnesium sulfate(Magnesium sulfate calculated by the clinical pharmacologist is much lower than the minimum effective dose in the clinic, so it does not need to gradually increase the dose). These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.16 mg/kg/hour lidocaine, 0.16 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
Protocol summary
Study aim
Determining the safety of Administration of Adenosine, Lidocaine, and Mg++(ALM) cocktail among Multiple Trauma Patients receiving Massive Transfusion and Admitted to the Resuscitation Room of Shahid Rajaee Trauma Hospital in Shiraz
Design
a single-center, phase 1 trial , on 17 paitients, without control group
Settings and conduct
Eligible patients who transferred from the scene of trauma to resuscitation room will be treated with cocktail.
Participants/Inclusion and exclusion criteria
Eligible age between 18 and 60 who are transported directly from the scene of their injury to the Resuscitation room at Shiraz Shahid Rajaei Trauma Center. The inclusion criteria will be the presence of multiple trauma (injury severity score>۱۶), whether blunt or penetrating, hypotension (SBP <۹۰ mmHg >۱۰۸ beats/min) or severe hypotension (SBP<۷۰mmHg) and who are a candidate to receive the third packed RBC. the paitients with severe underlying diseases (specially severe cardiac and pulmonary diseases and renal failure) ,and those who experienced slash thoracotomy, or if they have penetrating Traumatic brain injury or exposed brain matter. Also paitients with an irregular base ECG will be excluded from trial
Intervention groups
The cocktail will be started in a group of 4 patients. if safety is confirmed the dose will be increased in next three patients.The ALM combination will be administered as the bolus and maintenance IV fluid. The maximom bolus dose of ALM IV injection consists of 200cc of normal saline,(87mg) of 2% Lidocaine, (6 mg) of adenosine and (30mg) of magnesium sulfate .The maximum dose of drip combination consists of 0.16 mg/kg/hr lidocaine, 0.19 mg/kg/hr Adenosine, and 0.2 mg/kg/hr MgSO4.Every drip component should be injected from separate bottle in 300 cc normal saline .
Main outcome variables
side effects;reduction in mortality ,hospitalizatin time ,amount of pack cell recieved
General information
Reason for update
Due to the fact that the patients in the recovery room of the hospital usually receive up to 2 packs of blood and if needed, the rest of the blood is done in the inpatient departments or after transfer for better monitoring of the patients in the recovery room the criteria for inclusion in the study was changed instead of starting from the third pack to the second pack. Also, due to the lack of hypertonic saline, 3% of normal saline will be used in the blous dose.
Acronym
ALMIMTP
IRCT registration information
IRCT registration number:IRCT20230707058707N1
Registration date:2023-12-06, 1402/09/15
Registration timing:prospective
Last update:2023-12-19, 1402/09/28
Update count:4
Registration date
2023-12-06, 1402/09/15
Registrant information
Name
Soheil Sahafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3656 1547
Email address
soheilsahafi515@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the safety of Administration of Adenosine, Lidocaine, and Mg(ALM) cocktail among Multiple Trauma Patients receiving Massive Transfusion with dose escalation A phase I, clinical trial
Public title
Adenosine, lidocaone, and magnasium cocktail in massive transfusion patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Injury severity score more than 16
Systlic blood presure less than 70 or Systolic blood pressure less than 90 and heart rate more than 108
Candidate to recieve the second pack of packed red blood cell
Exclusion criteria:
Severe underlying disease specially cardiac, renal, and pulmonary
Paitient with slash thoracotomy
Penetrating brain injury or exposed brain matter
Paitients with irregular base electrocardiogram
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
17
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
This is a phase 1 clinical trial. The cocktail will be started with the minimum effective dose in a group of 4-5 patients then if the safety of the cocktail is confirmed the cocktail dose will be increased in the next three patients. The whole number of patients will be 17.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz, Islamic Republic Boulevard, Shiraz University Central Building, 5th floor
City
Shiraz
Province
Fars
Postal code
7194684471
Approval date
2023-11-25, 1402/09/04
Ethics committee reference number
IR.SUMS.REC.1402.395
Health conditions studied
1
Description of health condition studied
repairfusion injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
mortality
Timepoint
during hospital admission
Method of measurement
number of mortality in admited paitients
2
Description
recovery from trauma
Timepoint
At time of discharge from hospital
Method of measurement
duration of hospital admission
3
Description
amount of recieved blood
Timepoint
At the end of hospital admission
Method of measurement
amount of recieved pack cell
4
Description
amount of hemoglubin rise
Timepoint
before bolus after bolus and after drip
Method of measurement
cheking blood hemoglubin
5
Description
renal function
Timepoint
before bolus after bolus and after drip
Method of measurement
checking BUN and Cr
6
Description
improvement of clinical course
Timepoint
before bolus after bolus and after drip
Method of measurement
arterial blood gas
7
Description
severity of hemolysis
Timepoint
before bolus after bolus and after drip
Method of measurement
checking blood lactate dehydrogenase
8
Description
coagulopathy recovery
Timepoint
before bolus after bolus and after drip
Method of measurement
prothrombin time(PT), partial trombopalstin time(PTT), international normalized ratio(INR)
Secondary outcomes
empty
Intervention groups
1
Description
1st Intervention group: Adenosine lidocaine magnesium combination will be given to 4 eligible patients simultaneously with the second blood bag in two doses of bolus and infusion. If the safety of the cocktail is confirmed by the decision of the research team in the next group, the dose of the drug will be increased in next group. The cocktail dosage in first 4 patienst is as follows: the bolus dose consists of 200 cc of normal saline, 4 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 20 mg of lidocaine, 30 mg of magnesium sulfate. These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.08 mg/kg/hour lidocaine, 0.09 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
Category
Treatment - Drugs
2
Description
2end Intervention group: If the safety of the drug is confirmed in the previous stage, in this stage the dosage of the drugs will be slightly increased with the same implementation method as the previous group, which this time will be done on 5 patients. The cocktail dosage in this group is as follows: the bolus dose consists of 200 cc of normal saline, 6 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 40 mg of lidocaine, 30 mg of magnesium sulfate(Magnesium sulfate calculated by the clinical pharmacologist is much lower than the minimum effective dose in the clinic, so it does not need to gradually increase the dose). These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.1 mg/kg/hour lidocaine, 0.12 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
Category
Treatment - Drugs
3
Description
3rd Intervention group: If the safety of the drug is confirmed in the previous stage, in this stage the dosage of the drugs will be slightly increased with the same implementation method as the previous group, which this time will be done on 4 patients. The cocktail dosage in this group is as follows: the bolus dose consists of 200 cc of normal saline, 9 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 60 mg of lidocaine, 30 mg of magnesium sulfate(Magnesium sulfate calculated by the clinical pharmacologist is much lower than the minimum effective dose in the clinic, so it does not need to gradually increase the dose). These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.13 mg/kg/hour lidocaine, 0.14 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
Category
Treatment - Drugs
4
Description
4th Intervention group: If the safety of the drug is confirmed in the previous stage, in this stage the dosage of the drugs will be slightly increased with the same implementation method as the previous group, which this time will be done on 4 patients. The cocktail dosage in this group is as follows: the bolus dose consists of 200 cc of normal saline, 12 mg of adenosine (injected in one to two seconds with 20 cc of normal saline), 87 mg of lidocaine, 30 mg of magnesium sulfate(Magnesium sulfate calculated by the clinical pharmacologist is much lower than the minimum effective dose in the clinic, so it does not need to gradually increase the dose). These compounds will be injected separately. After injecting the bolus dose, the infusion dose will be injected within 4 hours. The infusion dose will include 0.16 mg/kg/hour lidocaine, 0.16 mg/kg/hour adenosine and 0.2 mg/kg/hour magnesium. Each of these drugs will be injected in 300 cc of normal saline.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Trauma Hospital
Full name of responsible person
Behzad Moazeni
Street address
Chyamran Blvd, Shahid Rajaee Hospital
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
rajaeehopital@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Vahid Hosseini
Street address
Zand Blvd, Shiraz Univercity Of Medical science
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Soheil Sahafi
Position
medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 286, 8th Ave., Molana Blvd., Sadra town
City
Shiraz
Province
Fars
Postal code
7199731554
Phone
+98 71 3656 1547
Email
soheilsahafi515@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Soheil Sahafi
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 286, 8th Ave, Molana Blvd., Sadra town
City
Shiraz
Province
Fars
Postal code
7199731554
Phone
00986561547
Email
soheilsahafi515@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Soheil Sahafi
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 286, 8th Ave, Molana Blvd., Sadra town
City
Shiraz
Province
Fars
Postal code
7199731554
Phone
+98 71 3656 1547
Email
soheilsahafi515@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available