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.: PACTR202302897543202 Date of Approval: 13/02/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Off-pump versus on-pump coronary artery bypass grafting in patients with chronic obstructive pulmonary disease
Official scientific title Off-pump versus on-pump coronary artery bypass grafting in patients with chronic obstructive pulmonary disease
Brief summary describing the background and objectives of the trial Chronic lung disease is a well-known risk factor for operative mortality from cardiac surgery, and, hence, it is included in EuroSCORE II. Chronic obstructive pulmonary disease (COPD) is inflammation of the airway, alveoli and small blood vessels, which leads to remodelling at the level of small airways.Patients with COPD are at a higher risk for postoperative complications, such as respiratory failure, pneumonia, atrial fibrillation (AF) and acute respiratory distress syndrome (ARDS). Despite the widely used CPB to perform CABG, off-pump CABG has become increasingly an area of interest because of the avoidance of the use of CPB and its associated systemic inflammatory response. Also, patients now have multiple morbid conditions, like diabetes, obesity, COPD and complex coronary artery disease (CCAD). A major benefit of CABG without CPB is that there is no aortic manipulation for aortic cannulation and no aortic cross-clamping. The aim of the present trial is to compare the outcome of coronary artery bypass grafting with and without cardiopulmonary bypass in patients of chronic obstructive pulmonary disease.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2020
Actual trial start date 01/01/2020
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL N/A
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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Off pump CABG N/A N/A CABG without using heart-lung machine 30
Control Group On pump CABG N/A N/A CABG using heart-lung machine and cold cardioplegia 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Preserved LV function, Left main disease and sinus rhythm. - Previous radiation to the chest - Previous sternotomy - Bilateral internal thoracic arteries harvesting - Chronic kidney disease - Emergency surgery - Re-exploration for bleeding - Combined cardiac surgery. 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 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 11/12/2019 Kafr Elsheikh University Scientific Research Ethic Committee
Ethics Committee Address
Street address City Postal code Country
ElGish street Kafr Elshikh 33511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome FEV1 Day 5 postoperative
Primary Outcome Respiratory failure During 3 months postoperatively
Secondary Outcome Pleural effusion During 3 months postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria New Medical Center ANMC 14 th May bridge Alexandria 21648 Egypt
Kafrelsheikh University Hospital ElGish street Kafrelsheikh 33511 Egypt
International Cardiac Center Bahaa Eldin Ghatwary Alexandria 21648 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Karim Mohamed Mady Green Towers Street Alexandria 21648 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cardiothoracic Surgery Department Faculty of Medicine Kafr Elshikh University El Gish street Kafrelsheikh 33511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Karim Mohamed Mady Green Towers Street Alexandria 21648 Egypt
Mohamed Mostafa Abdelaal Abo al Alaa Maary Kafr Elsheikh 33511 Egypt
Wael Mohamed Elfeky Abo Tabl Kafr Elsheikh 33511 Egypt
Amr Ahmed Abdou Ettish Insurance clinic street Alexandria 21648 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Abdelaal mohammed_abdelaal@med.kfs.edu.eg 00201001422577 Abo al Alaa Maary
City Postal code Country Position/Affiliation
Kafr Elsheikh 33511 Egypt Professor of Cardiothoracic Surgery Vice president of Kafr Elsheikh University
Role Name Email Phone Street address
Scientific Enquiries Wael Elfeky Wael_Elfiky@med.kfs.edu.eg 00201004332200 Abo Tabl
City Postal code Country Position/Affiliation
Kafr Elsheikh 33511 Egypt Professor and Head of Cardiothoracic Surgery Kafr Elsheikh University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: - Immediately following publication with no end date. - For anyone who wishes to access the data - For any type (purpose) of analyses - Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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