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.: PACTR202207785952318 Date of Approval: 08/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of Histidine -Tryptophan-Ketoglutarate cardioplegia alone or combined with preoperative infusion of levosimendan on vasoactive inotropic score in patients with poor cardiac function undergoing coronary artery bypass grafting
Official scientific title The effect of Histidine -Tryptophan-Ketoglutarate cardioplegia alone or combined with preoperative infusion of levosimendan on vasoactive inotropic score in patients with poor cardiac function undergoing coronary artery bypass grafting
Brief summary describing the background and objectives of the trial Patients with poor left ventricular function underegoing cardiac surgery frequently require inotropic drug support after cardiopulmonary bypass.Levosimendan is an effective agent , it enhances cardiac contractility and reduces cardiac workload. The study aims to assess the effect of Histidine -Tryptophan-Ketoglutarate cardioplegia alone or combined with preoperative infusion of levosimendan on vasoactive inotropic score in patients with poor cardiac function undergoing coronary artery bypass grafting.
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 Treatment: Drugs
Anticipated trial start date 30/06/2022
Actual trial start date 30/06/2022
Anticipated date of last follow up 01/01/2023
Actual Last follow-up date 01/01/2023
Anticipated target sample size (number of participants) 102
Actual target sample size (number of participants) 102
Recruitment status Active, not 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
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group levosimendan 0.1 mg/kg/min as continous infusion 12 hours preoperative 12 hours preoperative Levosimendan group will receive the drug 12 hours preoperative and HTK cardioplegia 51
Control Group normal saline 5o ml ,2ml/hr 12 hours preoperative placebo group will receive normal saline infusion 12 hours preoperative 51 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 40-60 poor cardiac function <40% isolated elective CABG NYHA class ll,lll & lv cross clamp time <120 minutes both sexes age<40 & >60 cardiac function >40% severe renal or hepatic disease severe mitral regurge Redo operation complex cardiac surgery patients with preoperative neurological deficits patient refusal Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 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 25/06/2022 Ain shams university Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
38 Abbasia ,cairo cairo 7154411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome vasoactive inotropic score 0 hour and 24 hours
Secondary Outcome vasoactive inotropic score at 48 hours , mechanical ventilation by hours ,ICU stay by days ,hospital days and systolic function assessed by transthoracic echocardiography 48 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cairo Ahmed farahat cairo 4521402 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Maha Elkotb 24 Ahmed farahat st,el ziton cairo 4521402 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Maha Elkotb 24 Ahmed farahat st, el ziton cairo 4521402 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Farouk kamal el din abd el aziz 37 mamdouh salem st ,nasr city cairo 4450113 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maha Elkotb mahaelkotb@gmail.com 01002138557 24 Ahmed farahat st,el ziton
City Postal code Country Position/Affiliation
cairo 4521402 Egypt assistant lecturer Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Farouk Kamal Eldin dr.faroukkamal@med.asu.edu.eg 0201066241179 137 Mamdouh salem Nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt lecturer of Anesthesia Ain Shams university
Role Name Email Phone Street address
Public Enquiries Maha Elkotb mahaelkotb@gmail.com 01002138557 24 Ahmed farahat st ,el ziton
City Postal code Country Position/Affiliation
cairo 4521402 Egypt assistant lecturerAin shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes I will give all IPD that underly the results of publication Informed Consent Form starting six month after publication controlled access after request for principal investigator
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