Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201710002696183 Date of Registration: 16/10/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Propofol versus insulin for myocardial protection assessed by ventricular biopsy and troponin I
Official scientific title Propofol versus insulin in cold cardioplegia for myocardial protection assessed by ventricular biopsy and troponin I in cases of on pump valvular cardiac surgery
Brief summary describing the background and objectives of the trial Cardiac damage from inadequate myocardial protection in on pump cardiac surgeries may cause low cardiac output syndrome which may lead to prolonged hospital stay, cost and delayed myocardial fibrosis Reperfusion injury is the main cause of myocardial damage in on pump cardiac surgery by reintroduction of free oxygen radicals into previously ischemic tissue which can further damage partially injured cells Reperfusion injury of myocardium has not been resolved even with blood cardioplegia although contains nutrients for ischemic myocardium indicating the need for other adjuvants to control myocardium metabolism and preventing intracellular acidosis This clincaltrial was designed to evaluate and compare the effects of adding either propofol or insulin to cold blood cardioplegia for myocardial protection in cases of on-pump valvular cardiac surgery. Primary endpoints : Myocardial protection asessed by left papillary muscle biopsy taken just after aortic cross clamping and before declamping and troponin I plasma level. Secondary endpoints : Postoperative left ventricular function assessed by trans-thoracic ECHO, time for weaning of mechanichal ventilation, postoperative morbidities (myocardial infarction, renal failure and need for dialysis), effect on liver functions and length of ICU stay.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,on pump valvular cardiac surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/03/2015
Actual trial start date 10/05/2015
Anticipated date of last follow up 10/04/2016
Actual Last follow-up date 08/05/2016
Anticipated target sample size (number of participants) 85
Actual target sample size (number of participants) 60
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised computer generated tables Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group drugs(cold blood cardioplegia in a ratio of 4:1.) 20 mmol potassium chloride 15% , 32 mmol magnesiumsulfate, 10 mmol sodium bicarbonate 8.4% , 100mg lidocaine hydrochloride 20% during period of on pumb machine the participants received cold blood cardioplegia in a ratio of 4:1. 20 Active-Treatment of Control Group
Experimental Group drug 10 IU of regular insulin for each one liter cold blood cardioplegic solution 10 IU of regular insulin during period of on pumb machine Received 10 IU of regular insulin for each one liter cold blood cardioplegic solution 20
Experimental Group drug 9 mg of propofol 10% added to cold blood cardioplegia 9 mg of propofol 10% during period of on pumb machine 1cm contained 10 mg of propofol 10% diluted with 9 cm sterile water with 1mg/ml then 9 cm ( 9mg) was added to each one liter of cold blood cardioplegic solution) 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-adult patients - aged between 18 to 60 years - of either sex - American society of Anesthiologist (ASA) physical status II and III -scheduled for elective on pump valvular cardiac surgery. 1) Previous cardiac surgery (redo). 2) Combined CABG and valvular cardiac surgery. 3) Emergency operation. 4) Chronic renal failure on dialysis. 5) Current congestive heart failure. 6) Poor Left ventricular (LV) function (i.e. LV function <30% ). 7) Diabetic patients . 8) Elevated serum troponin I levels. 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/02/2015 local ethics comittee of Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Cairo-Aswan agriculture road El-Minia 61511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome myocardial protection assessed by lt papillary biopsy and tropinin I -Biopsy from left pappilary muscle just after aortic cross clamping -- Biopsyjust before declamping preserved in 10% formalin and embedded in paraffin taken for histopathological examination by H and E stain -Troponin I level preoperative and at 12 hours after chest closure.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine-El-minia univeristy cairo-aswan agriculture road El-minia 61511 Egypt
El-minia univeristy hospital el-horria street El-minia 61511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine- Minia university cairo-aswan agriculture road El-minia 61511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine- Minia university cairo-aswan agriculture road El-minia 61511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mina Maher Raouf Eskander el-horria street El-minia 61511 Egypt
Omyma Shehata Mohamed. el-horria street El-minia 61511 Egypt
Shady Eid Elewany Taha hussien street El-minia 61511 Egypt
Heba Mohammad Tawfik el-horria street El-minia 61511 Egypt
Ibrahim Abbas youssef Taha hussien street El-minia 61511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mina Maher drmina2015@gmail.com 01015752424 El horria street
City Postal code Country Position/Affiliation
El-minia 61511 Egypt M.B.B.ch-M.S.c of anesthesia and I.C.U. Faculty of Medicine - Minia University.
Role Name Email Phone Street address
Public Enquiries Omyma mohamed omyma.shehata44@yahoo.com 01061762894 El horria street
City Postal code Country Position/Affiliation
El-minia 61511 Egypt Assistant Professor of Anesthesiology and I.C.U. Faculty of Medicine- Minia University.
Role Name Email Phone Street address
Scientific Enquiries Ibrahim youssef ibrahimabbas2005@yahoo.com 01060875736 taha hussien street
City Postal code Country Position/Affiliation
El-minia 61511 Egypt Professor of Anesthesiology and I.C.U. Faculty of Medicine- Minia University.
REPORTING
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