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.: PACTR202107885974137 Date of Approval: 05/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of remote ischemic preconditioning on liver function in patients subjected to Coronary Artery Bypass Graft Surgery .
Official scientific title Effect of Remote Ischemic Preconditioning on Liver Function following Coronary Artery Bypass Graft Surgery: A randomized controlled trial
Brief summary describing the background and objectives of the trial Cardiac surgery with cardiopulmonary bypass (CPB) is associated with multiple changes that can lead to dysfunction of major organs . The key mechanisms in CPB associated organ damage are: the activation of a systemic inflammatory response (SIRS), which is an inevitable consequence of CPB; hemodilution and reduced blood viscosity, mainly at the onset of CPB, resulting in alterations in the distribution of blood flow to organs and flow characteristics of blood through capillary networks;and ischemia/reperfusion injury (IRI) to multiple organs. During cardiac surgery, acute ischemice reperfusion (I/R) injury in organs other than the heart as the liver, kidneys, intestine, lungs and brain, is not uncommon and is associated with increased mortality and prolonged hospital stays . Post CPB hepatic dysfunction ranges from just mild hyperbilirubinaemia in 14-20 % of patients, up to a more severe form of hyperbilirubinaemia ( > 2mg/dl) associated with elevated liver enzymes (especially ALT> 90 Iu/l) and prolonged prothrombine time (50%) . Different pathophysiologic mechanisms incorporated in post CPB hepatic injury are; systemic inflammatory response syndrome (SIRS), oxidative stress, non-pulsatile flow, hypoperfusion and ischemic reperfusion injury (IRI) , Different therapeutic strategies for organ protection against acute IRI are available including remote ischemic preconditioning (RIPC), in which the application of one or more brief episodes of sublethal ischemia in tissues with high ischemic tolerance stimulates protection in distant organs from a subsequent severe insult . The investigators hypothesize that remote ischemic preconditioning would reduce postoperative increases in serum alanine transaminase (ALT) in patients who undergo CABG.The study objective is to evaluate the effects of remote ischemic preconditioning on liver function following on-pump CABG surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 05/07/2021
Actual trial start date 05/10/2021
Anticipated date of last follow up 05/09/2022
Actual Last follow-up date 05/09/2022
Anticipated target sample size (number of participants) 114
Actual target sample size (number of participants) 114
Recruitment status Completed
Publication URL unavailable
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo After induction, separate 9-cm blood pressure cuffs will be placed around the dominant upper arm . The placebo stimulus, an investigator will position the cuff under the operating cover and will squeeze the bulb with an opened air valve . three (5minutes) cycles of squeezing separated by 5 minutes periods . After induction, separate 9-cm blood pressure cuffs will be placed around the dominant upper arm . The placebo stimulus, an investigator will position the cuff under the operating cover and will squeeze the bulb with an opened air valve three (5minutes) cycles of squeezing separated by 5 minutes periods . 52 Placebo
Experimental Group RIPC After induction, separate 9-cm blood pressure cuffs will be placed around the dominant upper arm .The RIPC stimulus will be three (5minutes) cycles of cuff inflation to 200 mmHg separated by 5 minutes periods of cuff deflation. three (5minutes) cycles of cuff inflation to 200 mmHg separated by 5 minutes periods of cuff deflation. After induction, separate 9-cm blood pressure cuffs will be placed around the dominant upper arm .The RIPC stimulus will be three (5minutes) cycles of cuff inflation to 200 mmHg separated by 5 minutes periods of cuff deflation. 57
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients of either sex, age >18 years old who will be scheduled for elective or urgent CABG surgery . patient’s refusal, preoperative right sided heart failure, significant liver diseases, uncontrolled diabetes and/ or hypertention, preoperative renal diseases (serum creatinine ˃ 1.5 mg/dl), redo surgeries, and patients with significant acute or chronic upper limb ischemia Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 14/08/2017 Mansoura faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Algomhoria St. Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome serum alanine transaminase (ALT) .. at the 1st 24 postoperative hour
Secondary Outcome serum levels of AST, GGt, total and direct bilirubin, albumin and prothrombine concentration, aortic cross clamp time, bypass time, UOP, fluid balance at the end of CPB and at 24 postoperative hour, bleeding, transfusion( RBCs, FFP, platelets ),incidence of intraoperative hypotension, need for DC shocks, pacing, number of grafts, the amount of consumed inotropes and ,vasoactive drugs (vasopressors and dilators), Serum MDA, IL1, TNFα and IL10 will be measured at the following times; before RIPC, after RIPC, at 6,12,24,48, and 72 hours after the end of ischemic cardioplegic arrest and duration of mechanical ventilation and length of ICU stay. 6,12,24,48,72,hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospital Al Gomhoria street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University hospital Al gomhoria street Mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University Al Gomhoria Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr Nabiel Abdelraof Dr Mahmoud Abdelfattah. AlGomhoria Street Mansoura 35511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samah El Kenany sk_20022000@yahoo.com 00201002262557 Hay El gamaa
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Assistant professor of anesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Mahmoud Abdelfattah mahmoudabdelfattah945@gmail.com 00201006192325 Algomhoria
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt assistant lecturer of anesthesia and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries Nabil Abd Elraouf RASH_20012001@yahoo.com 00201001538648 Al Gomhoria street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Proffessor of anesthesia and surgical intensive care .
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes summary of results Study Protocol immediately following publication open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not applicable 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