Serum magnesium levels have changed following CABG so that Statistics hypomagnesaemia after CPB is 70 percent. Recently, the potential relationships between chronic administration of PPI and hypomagnesaemia have been reported. In this study believe that PPI effect on blood magnesium levels and its relationship with ventricular arrhythmia and AF in patients undergoing CABG- Off surgery were assessed. For stress ulcer prophylaxi, patients randomly assigned to a group of pantoprazole 40 mg twice a day intravenously when they are stay in the ICU and NPO. And 40 mg once a day orally during hospitalization in ICU (PO patient) and cardiac surgery (POST-ICU). and administered to the other half (the control group) Ranitidine 50 mg three times a day intravenously on days of hospitalization in ICU and NPO and famotidine 40 mg tablet once a day orally during hospitalization in ICU (PO patient), and cardiac surgery (POST-ICU). Hypomagnesaemia frequency will be compared between two groups.
General information
Acronym
Proton Pump Inhibitors (pantoprazol)
IRCT registration information
IRCT registration number:IRCT201511088384N5
Registration date:2016-07-17, 1395/04/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-17, 1395/04/27
Registrant information
Name
Arash Peivandi Yazdi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5209
Email address
peivandia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad university of medical sciences
Expected recruitment start date
2016-08-31, 1395/06/10
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of Proton Pump Inhibitors (pantoprazol) on Arrhythmia and Hypomagnesaemia Following off pump CABG
Public title
Effect of Proton Pump Inhibitors (pantoprazol) on Hypomagnesaemia
Purpose
Treatment
Inclusion/Exclusion criteria
بیماران کاندید جراحي CABG به روش off-pump وارد مطالعه خواهند شد. معيارهاي خروج از مطالعه شامل اين موارد مي باشد: عدم رضايت بيمار؛ بيماران تحت اعمال جراحي قلبي غير كرونري؛ بيماراني كه به هر دليلي تحت جراحي CABG به روش on-pump قرار ميگيرند؛ سابقه بيماري شناخته شده كليه شامل ناهنجاري هاي ساختماني؛ نارسايي كليه و يا بيماران single kidney؛ بيماري كه دچار ايست قلبي شده و CPR طولاني شده است؛ مواردCABG اورژانس؛ بيماران مبتلا به سوء تغذيه شديد؛ سابقه حساسيت به داروهاي مورد استفاده و يا بروز علائم افزايش حساسيت يا مسموميت با دارو؛ بيماران مبتلا به نارسايي قلبي با EF< 35%؛ وجود هرگونه آريتمي قلبی قبل عمل؛ سابقه مصرف داروهاي ضد آريتمي؛ سابقه CABG قبلي؛ داشتن اختلال الكتروليتي ( هيپو يا هيپر كالمي/ كلسمي ) قبل از شروع مطالعه؛ بيماران با ريسك فاكتور آريتمي مانند سندرم QT طولانی، QT كوتاه، بروگادا و غيره؛ بیماران با سابقه ناراحتی معده و تحت درمان با پنتوپرازول و H2 بلوکر.
Age
From 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
380
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad Research deputy of university of Medical Sciences
Ranitidine 50 mg three times a day intravenously on days of hospitalization in ICU and NPO and famotidine 40 mg tablet once a day orally during hospitalization in ICU (PO patient), and cardiac surgery (POST-ICU).
Category
Treatment - Drugs
2
Description
Pantoprazole 40 mg twice a day intravenously when they are stay in the ICU and NPO. And 40 mg once a day orally during hospitalization in ICU (PO patient) and cardiac surgery (POST-ICU).