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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202310853438175 Date of Registration: 11/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Whole-blood del Nido versus Cold Modified del Nido for Myocardial Protection
Official scientific title Tepid Whole-blood del Nido versus Cold Modified del Nido Cardioplegia for Myocardial Protection in adults undergoing elective cardiac surgery with cardiopulmonary bypass: Randomized Control Trail (RCT)
Brief summary describing the background and objectives of the trial Myocardial protection during cardiac surgery with cardiopulmonary bypass is an extremely crucial step, however; the ideal cardiologic solution type and temperature has always been a matter of debate. In adult cardiac surgical operations, del Nido cardioplegia has been shown to increase operative flow, myocardial protection, and clinical results. Many clinicians have already made modifications to the conventional formula. This study aims is to assess the effectiveness and tepid whole-blood del Nido versus cold modified del Nido cardioplegia in adults undergoing cardiac surgery. A significant aspect of our study is the evaluation of the rise in myocardial injury biomarkers in patients receiving the two forms of cardiplegia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/10/2023
Actual trial start date
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tepid Whole blood del Nido Cardioplegia 26 mEq KCl, 13 mEq 8.4% NaHCO3, 13 ml 25% Mannitol, 4 ml 50% MgSO4, 6.5 ml 2% Lidocaine, 200 ml Lactated Ringer Base at 28◦C temperature During cardiopulmonary bypass The tepid WB-DNC is generally prepared with whole blood by mixing minimal quantities of arresting and additive agents. The ingredients of WB-DNC will be prepared in two different 50 mL syringes. First syringe contains 6.6 mL magnesium sulfate (50%), 21.4 mL mannitol (25%), 20.6 mL NaHCO3 (8.4%), and 11.4 mL lidocaine (2%). The other 50 mL syringe contains only 50 mEq KCl. Delivery of filled ingredients was carried out through infusion pumps at a rate of 380 mL/hour at 28◦C 40
Control Group Cold modified del Nido 26 mEq KCl, 13 mEq 8.4% NaHCO3, 13 ml 25% Mannitol, 4 ml 50% MgSO4, 6.5 ml 2% Lidocaine, 800 ml Lactated Ringer Base at 4◦C temperature During cardiopulmonary bypass  The cold modified DNC will be prepared in on Lactated Ringer solution base. The ingredients of Del Nido will be prepared in two different 50 mL syringes. First syringe contains 6.6 mL magnesium sulfate (50%), 21.4 mL mannitol (25%), 20.6 mL NaHCO3 (8.4%), and 11.4 mL lidocaine (2%). The other 50 mL syringe contains only 50 mEq KCl. The Del Nido solution will then be mixed with autologous blood in crystalloid: blood ratio of 4:1. The solutions will be administered through a single dose of 20mL/kg, additional 500 ml will be given for patients having left ventricular hypertrophy (LVH). The delivery temperature of cardioplegia is 4°C, system pressure of 100–200mm Hg, and an administration flow of 200–300mL/min. If necessary, an additional maintenance doses (500ml each) every 60 minutes when the estimated cross-clamp time was over 90 minutes. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients referred for elective valve replacement surgery, ASD, VSD, or coronary artery bypass grafting surgery, or combined elective surgery - ASA classification II & III. Preoperative hemoglobin level < 12.0 g/dL Severe pulmonary hypertension Preoperative uncontrolled diabetes, Chronic renal failure requiring hemodialysis Poor left ventricular function (ejection fraction <30%) Preoperatively on intra-aortic balloon pump Patients with recent acute coronary syndrome Emergency procedures and Endocarditis Inability or unwillingness to give informed consent for participation. Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 28/08/2023 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 Troponin I enzyme at anesthesia induction, 2 hours and 24 hours post cardiopulmonary bypass
Primary Outcome CK-MB at anesthesia induction, 2 hours and 24 hours post cardiopulmonary bypass
Primary Outcome Need for Defibrillation Post declamping
Secondary Outcome Need for blood transfusion From the early post bypass period till two days postoperatively
Secondary Outcome Duration of inotropes immediate post bypass and throughout 48 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafrelsheikh University Hospital ElGish street Kafrelsheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hebatallah Fouad Dawood Building Number 2 Dream Compund, ElNassar Street, Smouha Alexandria 21648 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor 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
Amr Ahmed Abdou Ettish Insurance clinic street Alexandria 21648 Egypt
Hebatallah Fouad Dawood Building Number 2 Dream Compund, ElNassar Street, Smouha Alexandria 21648 Egypt
Mohamed Mamdouh Kotb Building Number 45 Street Number 314, Takseem AlKodaa, Smouha Alexandria 21646 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hebatallah Dawood Heba_fouad15@yahoo.com 00201010108228 Building Number 2 Dream Compund, ElNassar Street, Smouha
City Postal code Country Position/Affiliation
Alexandria 21648 Egypt Lecturer of Anesthesia and surgical Intensive care Faculty of Medicine Kafr Elsheikh University Egypt
Role Name Email Phone Street address
Scientific Enquiries Karim Mady Karimmady86@gmail.com 00201008263555 Green Towers Street
City Postal code Country Position/Affiliation
Alexandria 21648 Egypt Lecturer of Cardiothoracic surgery Faculty of Medicine Kafr Elsheikh University Egypt
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