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.: PACTR201604001601522 Date of Approval: 23/04/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of intraaortic Adenosine in Postconditioning during CABG Surgery
Official scientific title Role of intraaortic Adenosine in Postconditioning during CABG Surgery
Brief summary describing the background and objectives of the trial Adenosine has been shown to play a key role in various adaptive and protective responses to ischemia and has been suggested to mimic ischemic preconditioning. [1,2] Adenosine A -receptors have been shown to be widely distributed and possessing multiple functions that include cardioprotection, acceleration of glucose transport, stimulation of glycolysis, enhancement of lactate and ATP production with prolongation of time to ischemic contracture.There are three different types of Adenosine A-receptors; A1 receptors, which are situated on vascular smooth muscle cells and cardiomyocytes ; A2 receptors, which are located on endothelial and vascular smooth muscle cells; and A3 receptors, which are present on ventricular myocytes. [3] Many experimental and Clinical studies have shown that adenosine administration before ischemia or at the onset of reperfusion was able to reduce ischemia reperfusion injury. The mechanisms for its cardioprotection have been shown by many experimental studies that include activation of protein kinase C (PKC)-mediated pathway, which explains the cardioprotective effect provided by ischemic preconditioning (IPC). [4-8] However, few clinical trials in humans have studied the preconditioning- cardiac protective effect of adenosine during cardiac surgeries. [9,10] The aim of the current study is to evaluate the effect of adenosine -induced postconditioning on protection against myocardial ischemia/reperfusion injury in patients undergoing coronary artery bypass grafting (CABG) surgery.
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 Treatment: Drugs
Anticipated trial start date 28/04/2016
Actual trial start date 28/04/2016
Anticipated date of last follow up 03/04/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
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
Randomised Simple randomisation using a randomisation table created by a computer software program Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group postconditioning group The postconditioning group (no=30) will receive adenosine infusion (150µg/kg/min) diluted in 20 ml saline 0.9% 10 min. The postconditioning group (no=30) will receive adenosine infusion (150µg/kg/min) diluted in 20 ml saline 0.9% for 10 min via a cardioplegia needle into the aortic root started 10 min before aorta cross-clamp removal. 30
Control Group control group an equivalent volume of saline infusion as a placebo in a double-blind manner 10 min. the control group (no=30) will receive an equivalent volume of saline infusion as a placebo in a double-blind manner for 10 min via a cardioplegia needle into the aortic root started 10 min before aorta cross-clamp removal. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients undergoing elective CABG aged 40-70 y.with 2-4 Vessel disease EF in the range of 25-50%. age > 75 years, recent myocardial infarction, moderate to severe valvular lesions, hypertrophic obstructive cardiomyopathy (HOCM), pulmonary hypertension(mean pulmonary pressure >35mmhg), pericardial disease and infiltrative myocardial disease, patients with implantable pacemaker, emergency CABG, patients coming on inotropes, vasodilators or mechanical ventilation, significant pulmonary, hepatic or renal disease and oesophageal pathology. 40 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 04/04/2016 Ethical committee of Minoufiya Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
2Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The cardiac troponin I (cTnI) and creatine kinase isoenzyme MB (CK-MB), will be assessed before surgery as a baseline and at 4h,12h,24h and 48h after reperfusion.
Primary Outcome Ejection fraction (EF),fractional shortening(FS),Also we will assess signs of wall motion abnormalities(WMA). and cardiac index(CI) which will be measured by TEE.Also we will assess signs of wall motion abnormalities(WMA). 10 min. before going into cardiopulmonary bypass (T0),15 min (T1), 30 min (T2) and 60 min (T3) after weaning from bypass
Primary Outcome Diastolic function indices will be tested by (trans-mitral diastolic doppler flow profile) and tissue doppler imaging (TDI) will be recorded at the same time points of T0, T1, T2, T3
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minoufiya University hospital 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minoufiya University 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minoufiya University 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amany S Ammar 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
Khaled M Mahmoud 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
Ahmed Mokhtar Elkersh 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
Zeinab Abdel-Aziz Kasemy 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
Role Name Email Phone Street address
Public Enquiries khaled mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries khaled mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
REPORTING
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