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.: PACTR201907764652028 Date of Approval: 01/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cardioprotective effect of propofol in cardioplegia compared to systemic propofol in heart valves surgery; a randomized controlled trial
Official scientific title Cardioprotective effect of propofol in cardioplegia compared to systemic propofol in heart valves surgery; a randomized controlled trial
Brief summary describing the background and objectives of the trial Cardiac surgery now is surrounded by alot of risk factors and the myocardial protection strategies is the way for the researchers to find out. Our goal is to detect the cardioprotective effect of the propofol whether in cardioplegia or systemically.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/11/2018
Actual trial start date 11/11/2018
Anticipated date of last follow up 01/06/2020
Actual Last follow-up date 20/05/2022
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Completed
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Propofol in cardioplegia Dose of propofol in the cardioplegia : 10mic/ml Propofol in cardioplegia during cardiopulmonary bypass and every 25 minutes during aortic cross clamp. We will study the cardioprotective effect of the propofol if added to cardioplegia versus systemic propofol before and after aortic cross clamp during cardiopulmonary bypass of valvular heart surgery 50
Control Group Placebo in 50 patients will be as a controlled group. Placebo in the cardioplegia and in the aortic line before and after aoric cross clamp. The control group is 50 patients who will receive placebo in the cardioplegia and in the aortic line before and after aoric cross clamp and troponin T will be assessed preoperative, at arrival of the patient to ICU, 12 hours post-operative, 1 and 3 days post-operative. 50 Placebo
Experimental Group Propofol in the aortic line before and after aortic cross clamp 1 mg/kg The propofol will be given in the aortic line during cardiopulminary bypass before and after aortic cross clamp our aim is to detect the cardioprotective effect of the propofol if added to the cardioplegia versus systemically in the aortic line. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study will include all patients subjected to valve replacement or repair due to rheumatic affection. Those patients will be categorized into three groups: *Group 1(patients with propofol in the cardioplegia and placebo injection in the aortic line). *Group 2(patients with propofol injection in the aortic line before and after the aortic cross clamp and placebo injection in the cardioplegia). *Group 3(patients with placebo injection either in the cardioplegia and aortic line). Patients less than 18 years old and more than 70 years old. Patients with coronary artery disease. Patients subjected to complex aortic surgery(arch or root surgery). Patients with allergy to propofol. Emergency cardiac surgery. Redo cardiac surgery. Minimal invasive cardiac surgery. Non-rheumatic valve pathology. Patients with end stage renal failure. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 21/11/2018 Research Ethics Committee at Faculty of Medicine at Tanta University
Ethics Committee Address
Street address City Postal code Country
Elgeesh Street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cardiac troponin T level Preoperative, at arrival to the ICU, 12 hours post-operative, 1 and 3 days post-operative.
Secondary Outcome Echocardiography,liver function test,renal function test,cross clamp time,total bypass time, reperfusion time, recovery time,need for defibrilator, ICU stay and morbidty. Preoperative data, intraoperative data and post-operative data.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cardiothoracic Surgery Department at Tanta University Hospital Elgeesh Street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding Elgeesh Street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Hospital Elgeesh Street Tanta 31111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mahmoud Abo Elnasr omar abdelazez street tanta Egypt
Ehab Abd Elmonem Wahby elzamalek cairo Egypt
Abd Elhady Mohammed Taha Elgeesh tanta Egypt
Mohammad Abd Elmoneim Torky 14 Abbas-Elakkad street branched from Saied street Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amr Attia amr.atef@med.tanta.edu.eg 00201013833385 Shokry street
City Postal code Country Position/Affiliation
Elmahalla Elkobra Egypt Assistant lecturer of Cardiothoracic surgery at Tanta University Hospital
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abo Elnasr dr_mmaboelnasr@yahoo.com 00201003385855 Elgeesh Street
City Postal code Country Position/Affiliation
Tanta Egypt Assistant Professor of Cardiothoracic surgery at Tanta University Hospital
Role Name Email Phone Street address
Public Enquiries Ehab Wahby Ehab_wahby@hotmail.com 00201274711114 Elzamalk
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Cardiothoracic surgery at Tanta University Hospital
Role Name Email Phone Street address
Public Enquiries Abd Elhady Taha Abdelhadyt@gmail.com 00201005171381 Elgeesh Street
City Postal code Country Position/Affiliation
Tanta Egypt Professor of Cardiothoracic surgery at Tanta University Hospital
Role Name Email Phone Street address
Scientific Enquiries Mohammad Torky m.torky1982@yahoo.com 00201220180127 14 Abbas-Elakkad street branched from Saied street
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of Cardiothoracic surgery at Tanta University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes name,age,sex,coded number risk factors as: HTN,DM,COPD,AF,NYHA,Euroscore,smoking,prepheral vascular disease,carotid artery disease,sroke echocardiography preoperative and postoperative full laboratory investigation preoperative and postoperative troponin T level: preoperative,first hour of arrival to ICU, 12 hours postoperative,1 and 3 days postoperative operative data:total bypass time,cross clamp time,recovery time,reperfusion time,need for defibrilator,valve size postoperative data:ventilators hours,ICU stay,hospital stay,complications Informed Consent Form,Study Protocol 1-2 years controlled abstract and results will be permitted should contact us and we decide for permission criteria for request: full name,job,position,phone number,email,reason for access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information