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.: PACTR201804003249274 Date of Approval: 25/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Terlipressin infusion for prevention of vasoplegic syndrome in patients treated with ARBs undergoing CABG
Official scientific title Terlipressin infusion for prevention of vasoplegic syndrome in patients treated with angiotensin II receptor antagonist undergoing coronary artery bypass graft surgery: a randomized controlled study
Brief summary describing the background and objectives of the trial Preoperative use of renin angiotensin system antagonists has been considered an independent risk factor for development of vasoplegic syndrome. The aim of this study was to demonstrate efficacy of prophylactic terlipressin infusion for prevention of vasoplegic syndrome in patients treated with angiotensin receptor blocker undergoing coronary artery bypass graft surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,vasoplegic syndrome, coronary artery bypass graft surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/11/2017
Actual trial start date 01/11/2017
Anticipated date of last follow up 28/02/2018
Actual Last follow-up date 28/02/2018
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL https://asja.springeropen.com/articles/10.1186/s42077-020-0054-6
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 sequence sequentially numbered, opaque sealed envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group terlipressin infusion 1.3 ug kg-1 hour-1 6 hours patients on angiotensin II receptor antagonist scheduled for CABG. Anesthetic technique, surgical technique and cardiopulmonary bypass management were standardized. With the start of rewarming, patients received terlipressin infusion. 50 Placebo
Control Group Normal Saline infusion 1.3 ml hour-1 6 hours patients on angiotensin II receptor antagonist scheduled for CABG. Anesthetic technique, surgical technique and cardiopulmonary bypass management were standardized. With the start of rewarming, patients received Normal saline infusion. 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients on angiotensin II receptor antagonist losartan for at least 4 weeks before operation normal or mild impairment of left ventricular function (EF ¿ 40 by transthoracic echocardiography). Patients with a critical preoperative state were excluded from the study, including patients with intractable ventricular arrhythmias, previous aborted sudden cardiac death, preoperative mechanical ventilation, preoperative use of inotropes, preoperative use of intra-aortic balloon counter-pulsation, recent myocardial infarction. Patients with previous cardiac surgery, associated valvular heart disease, chronic lung disease, extra-cardiac arteriopathy, moderate to severe renal impairment were also excluded. 40 Year(s) 80 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 01/10/2017 Research Ethics Committee, faculty of medicine, ain shams university
Ethics Committee Address
Street address City Postal code Country
Abbasia, Cairo,, Egypt. Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of vasoplegic syndrome 60 minutes after weaning from CBP
Secondary Outcome inotropic score 60 minutes after weaning from CBP
Secondary Outcome vasopressor dependency index 60 minutes after weaning from CBP
Secondary Outcome Hemodynamic parameters: mean arterial blood pressure, central venous pressure, Cardiac index, systemic vascular resistance index. base-line reading before skin incision, immediately after weaning from CBP, then every 10 minutes, till 60 minutes after weaning from CBP.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams University Hospitals Abbasia Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams University Hospitals Abbasia, Cairo,, Egypt. Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals Abbasia Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Saleh Ahmed Department of Anesthesiology, Intensive Care Cairo 11566 Egypt
Sherine Kamal Zaki Kodeira Department of Anesthesiology, Intensive Care Cairo 11566 Egypt
Abdelkhalek Abdelmoneim Aboulseoud Department of Anesthesiology, Intensive Care Cairo 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Saleh drsalehm2002@hotmail.com +201227761463 Department of Anesthesiology, Intensive Care
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries Mohamed Saleh drsalehm2002@hotmail.com +201227761463 Department of Anesthesiology, Intensive Care
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Mohamed Saleh drsalehm2002@hotmail.com +201227761463 Department of Anesthesiology, Intensive Care
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Lecturer of anesthesia
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information