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Evaluation of high-dose anti-inflammatory effects of l-carnitine in patients with critical ill in the intensive care unit

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History
# Registration date Revision Id
2 2019-11-15, 1398/08/24 291488
1 2018-05-30, 1397/03/09 47473
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  • Protocol summary

    Determination of the effect of mega does l-carnitine supplementation on the level of inflammatory factors in patients with acute pulmonary respiratory distress syndrome in ICU
    Determination of the effect of mega does l-carnitine supplementation on the level of inflammatory factors in critically ill patients in ICU
    تعیین اثر مکمل یاری مگا دوز ال کارنیتین بر سطح فاکتور های التهابی در بیماران دچار سندرم دیسترس تنفسی حاد ریوی در ICU
    تعیین اثر مکمل یاری مگا دوز ال کارنیتین بر سطح فاکتور های التهابی در بیماران بدحال بستری در ICU
    This study was an interventional study and the number of 50 patients with acute pulmonary respiratory distress in the age range of 18-65 years old admitted to the intensive care unit of Imam Reza Hospitals of Mashhad introduced by a specialist after obtaining informed consent from patients or their companions will be included in the study.25 patients with ARDS are randomly assigned to case and control groups.
    This randomized and double-blind clinical trial with parallel and control groups will be conducted on 50 patients who will be randomly selected using the random number table.
    این مطالعه یک مطالعه مداخله ای بوده وتعداد50 بیمار دچار دیسترس تنفسی حاد ریوی در محدوده سنی 65-18سال بستری شده در بخش مراقبت های ویژه بیمارستان های امام رضا مشهد معرفی شده توسط متخصص مراقبت های ویژه پس از کسب رضایت نامه آگاهانه از بیماران یا همراهان آنها جهت شرکت در طرح كارآزمايي باليني داراي گروه كنترل تصادفي و كورسازي شده وارد مطالعه خواهند شد25 بیمار ARDS به گروه مورد و کنترل به صورت تصادفی تخصیص داده می شود. ورود هر بیمار به گروه مورد یا شاهد به صورت تصادفی و با کمک اعداد در پاکت های دربسته خواهد بود.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده بر روی 50 بیمار که برای تصادفی سازی از روش جدول اختصاصی تصادفی اعداد استفاده خواهد شد.
    imam reza
    Critically ill patients admitted to the intensive care unit to Imam Reza Hospital, Mashhad, Iran are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive the L-carnitine and control will receive placebo. The participants and person responsible for data collection are blind to group allocation and the type of treatment.
    50 بیمار ARDS به گروه مورد و کنترل به صورت تصادفی در بيمارستان امام رضا مشهد
    بیماران بدحال بستری در بخش مراقبت های ویژه بیمارستان امام رضا (ع)، مشهد انتخاب می شوند، مطالعه به صورت دو سوکور شده که از پاکت های مات در بسته برای پنهان سازی استفاده خواهد شد. گروه مداخله مکمل ال کارنیتین و گروه کنترل پلاسیبو را دریافت خواهند کرد. شرکت کنندگان و مسئول جمع آوری داده ها از اینکه چه كسي در چه گروهي قرار دارد و از نوع روش درمانی آگاهی ندارند.
    inclusion criteria:• Age of 18 -65 years, Conscious informed consent exteria criteria:Dissatisfaction with the patient or family of the patient to continue the intervention, Patients with liver and kidney failure, Patients who have cancer and are taking chemotherapy and cisplatin, Patients taking phenobarbital and phenytoin anti-inflammatory drugs,Patients taking pivolic acid, valproic acid, and fosfamide drugs,Patients undergoing dialysis.
    inclusion criteria:• Age of 18 years older, Conscious informed consent exteria criteria:Dissatisfaction with the patient or family of the patient to continue the intervention, Patients with liver and kidney failure, Patients who have cancer and are taking chemotherapy and cisplatin, Patients taking phenobarbital and phenytoin anti-inflammatory drugs,Patients taking pivolic acid, valproic acid, and fosfamide drugs,Patients undergoing dialysis.
    • معيار ورود سن 18 -65 سال ،رضایت نامه آگاهانه معيارخروج عدم رضایت بیمار یا خانواده بیمار جهت ادامه مداخله نارسايي كبدي وكليوي ،بيماران تحت دياليز،بیمارانی که سرطان دارند وتحت شیمی درمانی وداروی سیس پلاتین مصرف می کنند،بیمارانی که داروهای ضدتشنج فنوباربیتال وفنی توئین مصرف می کنند،بیمارانی که داروهای پیوالیک اسید،والپیروئیک اسید وافوسفامید مصرف می کنند.
    • معيار ورود سن 18 سال به بالا ،رضایت نامه آگاهانه معيارخروج عدم رضایت بیمار یا خانواده بیمار جهت ادامه مداخله نارسايي كبدي وكليوي ،بيماران تحت دياليز، بیمارانی که سرطان دارند و تحت شیمی درمانی و داروی سیس پلاتین مصرف می کنند،بیمارانی که داروهای ضدتشنج فنوباربیتال وفنی توئین مصرف می کنند،بیمارانی که داروهای پیوالیک اسید،والپیروئیک اسید وافوسفامید مصرف می کنند.
    25 patients with ARDS are randomly assigned to case and control groups. The entry of each patient into the case or control group will be randomized with the help of numbers in sealed envelopes. After obtaining consent, 10 cc blood samples are taken from blood patients to evaluate the serum level of L-carnitine and blood samples are taken to evaluate the inflammatory and oxidative factors in a negative 80 ° C refrigerator. At the beginning of the study, APACHEII, The organ failure function questionnaire (SOFA) and patient nutrition status questionnaire (Nutric score) are obtained from patients.Then the patient's body mass index (BMI), demographic characteristics, laboratory data and drug and dietary information are recorded for each patient. كار
    The intervention group will receive 3000 mg L-carnitine liquid supplements (Darou Pakhsh, Tehran, Iran), orally for 7 days. The control group will receive placebo (pasteurized drinking water) orally for 7 days.
    25 بیمار ARDS به گروه مورد و کنترل به صورت تصادفی تخصیص داده می شود. ورود هر بیمار به گروه مورد یا شاهد به صورت تصادفی و با کمک اعداد در پاکت های دربسته خواهد بود. پس از کسب رضایت در طرح از بیماران 10 سی سی خون جهت ارزیابی سطح سرمی ال کارنیتین گرفته می شود ونمونه خون جهت بررسی فاکتورهای التهابی واسترس اکسیداتیو در فریزر منفی 80 درجه سیلسیوس نگهداری میشوند.در شروع مطالعه پرسشنامه های بررسی شدت بیماری(APACHEⅡ)، پرسشنامه ارزیابی نقص عملکرد ارگان (SOFA) و پرسشنامه بررسی وضعیت تغذیه بیمار در ICU (Nutric score) از بیماران اخذ می گردسپس شاخص توده بدنی بیماران(BMI)،مشخصات دموگرافیک ،داده های آزمایشگاهی و اطلاعات کاردکس دارویی و رژیمی برای هر بیمار ثبت می شود. در انتها مطالعه دوباره تمام مراحل تكرار مي شود.
    گروه مداخله روزانه 3000 میلی گرم مکمل های مایع ال کارنیتین (دارو پخش، تهران، ایران) به صورت خوراکی به مدت 7 روز دریافت خواهند کرد. گروه کنترل روزانه یک عدد قرص پلاسیبو (آب آشامیدنی پاستوریزه) را به صورت خوراکی به مدت 7 روز دریافت خواهند کرد.
    in
    Inflammation factors

  • General information

    65
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    Year
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    No
    Yes
    1
    1
    Other
    Parallel
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    50
    2018-08-25, 1397/06/03
    2019-06-09, 1398/03/19
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    2018-07-01, 1397/04/10
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    2019-09-21, 1398/06/30
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    2019-10-02, 1398/07/10
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    Title change
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    تغییر عنوان
    Evaluation of high-dose anti-inflammatory effects of l-carnitine in patients with acute respiratory distress syndrome in the intensive care unit
    Evaluation of high-dose anti-inflammatory effects of l-carnitine in patients with critical ill in the intensive care unit
    بررسی اثرات ضد التهابی مکملیاری با دوز بالای ال کارنیتین در بیماران با سندرم دیسترس تنفسی حاد در بخش مراقبت های ویژه
    بررسی اثرات ضد التهابی مکملیاری با دوز بالای ال کارنیتین در بیماران بدحال بستری در بخش مراقبت های ویژه
    Age of 18 -65 years
    Conscious informed consent
    Patients with acute respiratory distress syndrome
    Patients with recently diagnosed acute respiratory distress syndrome
    Age of 18 years older
    Conscious informed consent
    Critical ill patients
    Patients with recently diagnosed critical ill
    سن 18 -65 سال
    رضایت نامه آگاهانه
    بيماران داراي ديسترس تنفسي حاد ريوي باشند
    بيماران داراي ديسترس تنفسي حاد ريوي تازه تشخيص داده شده
    سن 18 سال وبالاتر
    رضایت نامه آگاهانه
    بيماران بدحال بستری در بخش مراقبت های ویژه باشند
    بیماران بدحال تازه تشخیص داده شده
    In this study, commercially available l-carnitine supplements with a dose of 3000 Mg and pasteurized drinking water as a randomly packaged placebo (blinded) are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of gastritis.
    In this study, patients will be administered commercial L-carnitine liquid supplements at a dose of 3000 mg. Pasteurized drinking water will be used as a placebo. These will be randomly packaged and concealed (blinded) by a nurse. The medical team and the nutrition team will monitor the administration every day at specific hours. The patients will be given these supplements via gavage for a period of 7 days.
    در این مطالعه مکمل های مایع ال کارنیتین تجاری با دوز 3000 میلیگرم و آب آشامیدنی پاستوریزه به عنوان پلاسبو که به صورت تصادفی بسته بندی شده و پوشیده شده (کور سازی) توسط پرستار و با نظارت هر روز تیم پزشکی و تیم تغذیه در ساعات مشخص به مدت 21 روزبه بیماران گاواژ می شود در ابن مطالعه برای دریافت ال کارنیتین از بیماران هزینه ای دریافت نمی شود و ال کارنیتین موجود در مطالعه توسط شرکت داروپخش تامین می شود..این مطالعه برای مجری وهمکاران طرح هیچ گونه منافع اقتصادی ندارد و در مقاله منتج از آن در قسمت تضاد منافع نام شرکت تامین کننده ال کارنیتین ذکر خواهد شد.
    در این مطالعه مکمل های مایع ال کارنیتین تجاری با دوز 3000 میلیگرم و آب آشامیدنی پاستوریزه به عنوان پلاسبو که به صورت تصادفی بسته بندی شده و پوشیده شده (کور سازی) توسط پرستار و با نظارت هر روز تیم پزشکی و تیم تغذیه در ساعات مشخص به مدت 7 روزبه بیماران گاواژ می شود.

  • Health conditions studied

    #1
    J80
    R69
    Acute respiratory distress syndrome
    Illness, unspecified
    Acute respiratory distress syndrome
    Critical ill in intensive care units
    سندرم ديسترس تنفسي حاد ريوي
    بیماران بدحال در بخش مراقبت های ویژه

  • Primary outcomes

    #1
    ابتداي مطالعه (قبل از شروع مداخله)،انتهاي مطالعه روز 21
    ابتداي مطالعه (قبل از شروع مداخله)، انتهاي مطالعه روز 21

  • Secondary outcomes

    #1
    before and after study
    Before and after study
    ابتدا وانتها مطالعه
    ابتدا و انتها مطالعه
    #2
    MAC
    Mid-arm circumference (MAC)
    محیط دور بازو(MAC)
    محیط دور بازو (MAC)
    before and after study
    Before and after study
    ابتدا وانتها مطالعه
    ابتدا و انتها مطالعه
    #3
    APACHEⅡ questionair
    Severity of illness
    پرسشنامه APACHEⅡ
    شدت بیماری
    before and after study
    Before and after study
    ابتدا وانتها مطالعه
    ابتدا و انتها مطالعه
    in this study, APACHEII questionnaire will be complimented.
    Based on APACHEII questionnaire
    در مطالعه پرسشنامه بررسی شدت بیماری(APACHEⅡ) تكميل خواهد شد
    بر اساس پرسشنامه بررسی شدت بیماری (APACHEⅡ)
    #4
    SOFA
    Examining organ dysfunction
    پرسشنامه SOFA
    بررسی نقص عملكرد ارگان
    before and after study
    Before and after study
    in this study, SOFA questionnaire will be complimented.
    Based on sequential organ failure assessment (SOFA) questionnaire
    در مطالعه پرسشنامه بررسی نقص عملكرد ارگان تكميل خواهد شد
    بر اساس پرسشنامه ارزیابی متوالی نارسایی اندام SOFA
    #5
    پرسشنامه NUTRIC score
    بررسی وضعيت تغذيه اي پرسشنامه NUTRIC score
    before and after study
    Before and after study
    ابتدا وانتها مطالعه
    ابتدا و انتها مطالعه
    in this study, NUTRIC score questionnaire will be complimented.
    Based on Nutrition Risk in Critically ill (NUTRIC) questionnaire
    در مطالعه پرسشنامه بررسی وضعيت تغذيه اي تكميل خواهد شد
    بر اساس پرسشنامه خطر تغذیه در بیماران بدخیم (NUTRIC)
    #6
    سطح پروتئین واکنشگر فاز حاد CRP و سطح سیتوکین های التهابی وضدالتهابی که شامل IL-10 ،IL-8 ،IL-6 ،IL-4 ،IL-2 ،IL-1 β ،IFN-γ ،TNF-α
    سطح پروتئین واکنشگر فاز حاد CRP و سطح سیتوکین های التهابی و ضدالتهابی که شامل IL-10 ،IL-8 ،IL-6 ،IL-4 ،IL-2 ،IL-1 β ،IFN-γ ،TNF-α
    before and after study
    Before and after study
    #7
    procalcitonin Factor
    Procalcitonin Factor
    فاکتورپروکلسی تونین
    فاکتور پروکلسی تونین

  • Intervention groups

    #1
    intervention groups:25 patients with ARDS who receive commercially available l-carnitine supplements with a dose of 3000 Mg are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of Gavage.
    intervention groups:25 patients with critical ill who receive commercially available l-carnitine supplements with a dose of 3000 Mg are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of Gavage.
    گروه مداخله:25 بیمار ARDS که روزانه مکمل های مایع ال کارنیتین تجاری با دوز 3000 میلیگرم دریافت میکنند با نظارت هر روز تيم پزشكي و تيم تغذيه در ساعات مشخص سه بار در روز هر بار يك گرم به مدت 21 روز گاوا‍‍‍‍‍‍‍‍‍ژ ميشود ال كارنيتين موجود توسط شركت داروپخش تامين مي شود
    گروه مداخله:25 بیمار critical ill که روزانه مکمل های مایع ال کارنیتین تجاری با دوز 3000 میلیگرم دریافت میکنند با نظارت هر روز تيم پزشكي و تيم تغذيه در ساعات مشخص سه بار در روز هر بار يك گرم به مدت 21 روز گاوا‍‍‍‍‍‍‍‍‍ژ ميشود ال كارنيتين موجود توسط شركت داروپخش تامين مي شود
    #2
    Control group: 25 patients with ARDS who receive pasteurized drinking water as a randomly packaged placebo are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of Gavage,the placebo is made that medical University of mashhad.Intervention groups and control groups are randomly assigned to case and control groups.
    Control group: 25 patients with Critical ill who receive pasteurized drinking water as a randomly packaged placebo are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of Gavage,the placebo is made that medical University of mashhad.Intervention groups and control groups are randomly assigned to case and control groups.
    گروه کنترل: 25 بیمار ARDS که روزانه آب آشامیدنی پاستوریزه به عنوان پلاسبو دریافت میکنند با نظارت هر روز تيم پزشكي وتغذيه 3 بار در روز هر بار يك گرم همانند گروه مداخله به مدت 21 روز گاواژ مي شود وساخت پلاسبو در دانشكده داروسازي دانشگاه مشهد انجام ميشود. گروه مداخله و گروه کنترل به صورت تصادفی تخصیص داده می شود.
    گروه کنترل: 25 بیمار critical ill که روزانه آب آشامیدنی پاستوریزه به عنوان پلاسبو دریافت میکنند با نظارت هر روز تيم پزشكي وتغذيه 3 بار در روز هر بار يك گرم همانند گروه مداخله به مدت 21 روز گاواژ مي شود وساخت پلاسبو در دانشكده داروسازي دانشگاه مشهد انجام ميشود. گروه مداخله و گروه کنترل به صورت تصادفی تخصیص داده می شود.

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohsen tafaghodii
    Full name of responsible person - Persian: دكتر محسن تفقدي
    Street address - English: Khorasan Razavi - Mashhad University Street- opposite Khayyayan University 18- Mashhad University of Medical Sciences-
    Street address - Persian: خراسان رضوی - مشهد-خیابان دانشگاه- روبروی خیایان دانشگاه 18- دانشگاه علوم پزشکی مشهد-
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 91778 99191
    Phone: +98 51 3841 1538
    Fax: +98 51 3843 0249
    Email: tafaghodim@mums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohsen Tafaghodii
    Full name of responsible person - Persian: دكتر محسن تفقدي
    Street address - English: Khorasan Razavi - Mashhad University Street- Opposite Of Daneshgah St. 18- Mashhad University Of Medical Sciences-
    Street address - Persian: خراسان رضوی - مشهد-خیابان دانشگاه- روبروی خیایان دانشگاه 18- دانشگاه علوم پزشکی مشهد-
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 91778 99191
    Phone: +98 51 3841 1538
    Fax: +98 51 3843 0249
    Email: Tafaghodim@mums.ac.ir
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Abdolreza Norozi
    Full name of responsible person - Persian: عبدالرضا نوروزي
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: sub_specialist
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Khorasan Razavi - Mashhad University Street- Opposite of Daneshgah 18- Mashhad University of Medical Sciences-
    Street address - Persian: خراسان رضوی - مشهد-خیابان دانشگاه- روبروی خیایان دانشگاه 18- دانشگاه علوم پزشکی مشهد-
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 91778-99191
    Phone: +98 51 3882 7034
    Mobile: +98 912 712 6991
    Fax:
    Email: Norouzya@mums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Abdolreza Norozi
    Full name of responsible person - Persian: عبدالرضا نوروزي
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: sub_specialist
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Imam Reza Hospital, Imam Reza Square
    Street address - Persian: میدان امام رضا، بیمارستان امام رضا
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9137913316
    Phone: +98 51 3882 7034
    Mobile: +98 912 712 6991
    Fax:
    Email: Norouzya@mums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Abdolreza Norozi
    Full name of responsible person - Persian: عبدالرضا نوروزي
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: sub_specialist
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Khorasan Razavi - Mashhad University Street- opposite Khayyayan University 18- Mashhad University of Medical Sciences-
    Street address - Persian: خراسان رضوی - مشهد-خیابان دانشگاه- روبروی خیایان دانشگاه 18- دانشگاه علوم پزشکی مشهد-
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 91778-99191
    Phone: +98 51 3882 7034
    Mobile: +98 912 712 6991
    Fax:
    Email: Norouzya@mums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Abdolreza Norozi
    Full name of responsible person - Persian: عبدالرضا نوروزي
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: sub_specialist
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Imam Reza Hospital, Imam Reza Square
    Street address - Persian: میدان امام رضا، بیمارستان امام رضا
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9137913316
    Phone: +98 51 3882 7034
    Mobile: +98 912 712 6991
    Fax:
    Email: Norouzya@mums.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Sedaghat
    Full name of responsible person - Persian: علیرضا صداقت
    Position - English: Associated professor
    Position - Persian: استاديار
    Latest degree: sub_specialist
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran
    Street address - Persian: خیابان دانشگاه
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9177899191
    Phone: +98 51 3802 3701
    Mobile: +98 915 311 9505
    Fax: +98 51 3841 3006
    Email: sedaghatar@mums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Farveh Yahyapour
    Full name of responsible person - Persian: فروه یحیی پور
    Position - English: MSC Student
    Position - Persian: دانشجوی کارشناسی ارشد تغذیه
    Latest degree: master
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Imam Reza Hospital, Imam Reza Square
    Street address - Persian: میدان امام رضا، بیمارستان امام رضا
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9177899191
    Phone: +98 51 3802 3701
    Mobile: +98 937 010 4013
    Fax: +98 51 3841 3006
    Email: yahyapourof951@mums.ac.ir
    Web page address:

  • Sharing plan

    Evaluation of high-dose anti-inflammatory effects of lcarnitine in patients with acute respiratory distress syndrome in the intensive care unit
    Evaluation of high-dose anti-inflammatory effects of lcarnitine in critical ill patients in the intensive care unit
    بررسی اثرات ضد التهابی مکملیاری با دوز بالای ال کارنیتین در بیماران با سندرم دیسترس تنفسی حاد در بخش مراقبت های ویژه
    بررسی اثرات ضد التهابی مکملیاری با دوز بالای ال کارنیتین در بیماران بدحال بستری در بخش مراقبت های ویژه
    This may be provided as an absolute date 1397,starting 6 months after publication
    This may be provided as an absolute date 1398,starting 6 months after publication
    شروع دوره دسترسی از سال 1397 " و "شروع دوره دسترسی 6 ماه پس از چاپ نتایج
    شروع دوره دسترسی از سال 1398 " و "شروع دوره دسترسی 6 ماه پس از چاپ نتایج
    Alireza sedaghat ,Abdolreza norozi
    The research data is exclusively accessible to the researchers working at universities and centers for scientific research
    دكترعليرضا صداقت و دكتر عبدالرضا نوروزي
    داده های ما فقط برای محققین شاغل در موسسات دانشگاهی و علمی در دسترس خواهد بود.
    استفاده ازداده ها فقط بعد انتشار مقاله امكانپذير است.
    استفاده از داده ها فقط بعد انتشار مقاله امكانپذير است.
    6 ماهonth
    6 ماه

Protocol summary

Study aim
Determination of the effect of mega does l-carnitine supplementation on the level of inflammatory factors in critically ill patients in ICU
Design
This randomized and double-blind clinical trial with parallel and control groups will be conducted on 50 patients who will be randomly selected using the random number table.
Settings and conduct
Critically ill patients admitted to the intensive care unit to Imam Reza Hospital, Mashhad, Iran are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive the L-carnitine and control will receive placebo. The participants and person responsible for data collection are blind to group allocation and the type of treatment.
Participants/Inclusion and exclusion criteria
inclusion criteria:• Age of 18 years older, Conscious informed consent exteria criteria:Dissatisfaction with the patient or family of the patient to continue the intervention, Patients with liver and kidney failure, Patients who have cancer and are taking chemotherapy and cisplatin, Patients taking phenobarbital and phenytoin anti-inflammatory drugs,Patients taking pivolic acid, valproic acid, and fosfamide drugs,Patients undergoing dialysis.
Intervention groups
The intervention group will receive 3000 mg L-carnitine liquid supplements (Darou Pakhsh, Tehran, Iran), orally for 7 days. The control group will receive placebo (pasteurized drinking water) orally for 7 days.
Main outcome variables
Inflammation factors

General information

Reason for update
Title change
Acronym
IRCT registration information
IRCT registration number: IRCT20151108024938N2
Registration date: 2018-05-30, 1397/03/09
Registration timing: prospective

Last update: 2024-01-11, 1402/10/21
Update count: 1
Registration date
2018-05-30, 1397/03/09
Registrant information
Name
Alireza Sedaghat
Name of organization / entity
Mashhad university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 3701
Email address
sedaghatar@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-09, 1397/03/19
Expected recruitment end date
2019-06-09, 1398/03/19
Actual recruitment start date
2018-07-01, 1397/04/10
Actual recruitment end date
2019-09-21, 1398/06/30
Trial completion date
2019-10-02, 1398/07/10
Scientific title
Evaluation of high-dose anti-inflammatory effects of l-carnitine in patients with critical ill in the intensive care unit
Public title
Evaluation of high-dose anti-inflammatory effects of l-carnitine
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 years older Conscious informed consent Critical ill patients Patients with recently diagnosed critical ill
Exclusion criteria:
Dissatisfaction with the patient or family of the patient to continue the intervention Patients with liver and kidney failure Patients who have cancer and are taking chemotherapy and cisplatin Patients taking phenobarbital and phenytoin anti-inflammatory drugs Patients taking pivolic acid, valproic acid, and fosfamide drugs Patients undergoing dialysis
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 50
More than 1 sample in each individual
Number of samples in each individual: 2
at first and at the end of study has been take the blood (10 cc)
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
25 patients with ARDS are simple randomly assigned to case and control groups. The entry of each patient into the case or control group will be randomized with the help of numbers in sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients will be administered commercial L-carnitine liquid supplements at a dose of 3000 mg. Pasteurized drinking water will be used as a placebo. These will be randomly packaged and concealed (blinded) by a nurse. The medical team and the nutrition team will monitor the administration every day at specific hours. The patients will be given these supplements via gavage for a period of 7 days.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of medical university of mashhad
Street address
imam reza hospital,daneshgah street,Mashhad,Iran
City
mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2018-04-09, 1397/01/20
Ethics committee reference number
IR.MUMS.fm.REC.1396.671

Health conditions studied

1

Description of health condition studied
Critical ill in intensive care units
ICD-10 code
R69
ICD-10 code description
Illness, unspecified

Primary outcomes

1

Description
IL-6
Timepoint
The first of study,the end of study 21th day
Method of measurement
ELISA

Secondary outcomes

1

Description
Anthropometric indices
Timepoint
Before and after study
Method of measurement
ELISA

2

Description
Mid-arm circumference (MAC)
Timepoint
Before and after study
Method of measurement
. The height of each patient is measured in the lying state or through the length of the ulna and the circumference of the middle of the non-dominant hand arm with a non-transient strip meter with an accuracy of 5.5 cm.

3

Description
Severity of illness
Timepoint
Before and after study
Method of measurement
Based on APACHEII questionnaire

4

Description
Examining organ dysfunction
Timepoint
Before and after study
Method of measurement
Based on sequential organ failure assessment (SOFA) questionnaire

5

Description
NUTRIC score questionnaire
Timepoint
Before and after study
Method of measurement
Based on Nutrition Risk in Critically ill (NUTRIC) questionnaire

6

Description
Acute Phosphorus Reactive Protein Level (CRP) Level - Inflammatory Cytokines Levels Including IL-10, IL-8 , IL-6, IL-4, IL-2, IL-1 β, IFN-γ, TNF-α
Timepoint
Before and after study
Method of measurement
ELISA

7

Description
Procalcitonin Factor
Timepoint
before and after study
Method of measurement
ELISA

Intervention groups

1

Description
intervention groups:25 patients with critical ill who receive commercially available l-carnitine supplements with a dose of 3000 Mg are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of Gavage.
Category
Treatment - Drugs

2

Description
Control group: 25 patients with Critical ill who receive pasteurized drinking water as a randomly packaged placebo are given to the patients by nurses and supervised by the team during the specified period of time for 21 days in the treatment of Gavage,the placebo is made that medical University of mashhad.Intervention groups and control groups are randomly assigned to case and control groups.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emamreza hospitals
Full name of responsible person
Alireza sedaghat
Street address
Emam reza hospital,daneshgah AVE
City
Mashhhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3802 3701
Fax
+98 51 3871 3638
Email
SedaghatAr@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodii
Street address
Khorasan Razavi - Mashhad University Street- Opposite Of Daneshgah St. 18- Mashhad University Of Medical Sciences-
City
Mashhad
Province
Razavi Khorasan
Postal code
91778 99191
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Abdolreza Norozi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nutrition
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3882 7034
Email
Norouzya@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abdolreza Norozi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Nutrition
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3882 7034
Email
Norouzya@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farveh Yahyapour
Position
MSC Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3802 3701
Fax
+98 51 3841 3006
Email
yahyapourof951@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Evaluation of high-dose anti-inflammatory effects of lcarnitine in critical ill patients in the intensive care unit
When the data will become available and for how long
This may be provided as an absolute date 1398,starting 6 months after publication
To whom data/document is available
The research data is exclusively accessible to the researchers working at universities and centers for scientific research
Under which criteria data/document could be used
Use of the data is only possible after publication of the article.
From where data/document is obtainable
Mashhad medical university, yahyapourof951@mums.ac.ir ,farvehyahyapour,
What processes are involved for a request to access data/document
6 Months
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