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.: PACTR202207730603285 Date of Approval: 14/07/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy and Safety of Modified Del Nido Cardioplegia in Adult Cardiac Surgeries
Official scientific title Efficacy and Safety of Modified Del Nido Cardioplegia in Adult Cardiac Surgeries: A Randomized Control Trial
Brief summary describing the background and objectives of the trial Cardioplegia is an integral and essential method for myocardial protection for patients of all ages requiring cardiac surgery. Myocardial protection with cardioplegia is an integral component of most cardiac surgical procedures by limiting metabolic activity and increasing myocardium’s capacity to withstand ischemia for prolonged periods of time. Plenty of solutions are available, both commercial and self-made. Yet, there are no guidelines referring to use of a specific solution, and the literature does not clearly confirm the superiority of one over another. Del Nido cardioplegia is calcium free extracellular Cardioplegia solution. The components of Del Nido Cardioplegia are not unique, as most of those components are used intra-operatively during cardiopulmonary bypass (CPB) at different phases and in various combinations. However, the combination is unique in that the overall effect on the myocardial protection is synergistic allowing for longer dosing interval. Unfortunately, an unavailability of Plasma-Lyte A (the basic solution for the Del Nido cardioplegia) in many countries precluding utilization of del Nido cardioplegia with its original base solution. In this study, we will assess the efficacy and safety of the Del Nido cardioplegia using a crystalloid based solution rather than the original base solution (Plasma-Lyte A) while maintaining the final electrolytes composition and pH (Modified Del Nido cardioplegia). The aim of this work is to assess the efficacy and safety of modified Del Nido cardioplegia compared with conventional blood cardioplegia in adult patients undergoing cardiac surgeries.
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 Assessing efficacy and safety of modified Del Nido cardioplegia compared with conventional blood cardioplegia in adult patients undergoing cardiac surgeries.
Anticipated trial start date 15/11/2020
Actual trial start date
Anticipated date of last follow up 30/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 74
Actual target sample size (number of participants)
Recruitment status Completed
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Modified Del Nido cardioplegia 50 ml/Kg with a maximum dose of 1 L. For 90 minutes starting immediately post aortic cross clamping. It is given over 1-2 min with pressure 100-200 mmHg. The cardioplegia solution is prepared as follows: Base: *Normal saline 0.9 % 800 ML, - Potassium chloride 2 mEq/ml 26 mEq - Magnesium sulfate 10% 25 ml (2.5 gm) - Lidocaine 2% 6.5 ml - Sodium Bicarbonate 8.4%,1 mEq/ml 13 mEq - Mannitol 20% 16 ml - Crystalloid: blood ratio 4:1 *Normal saline (Na 154 mEq, CL 154, pH 5.5) pH for the Modified Del Nido Cardioplegia solution is 9.5 The modified Del Nido solution is administrated at temperature 2-6 C, with a dose 20 ml/kg (The maximum dose is limited to 1 L for patients larger than 50 Kg). A smaller arresting dose of 10 ml /kg may be used for procedure requiring a cross clamp times less than 30 minutes. Subsequent doses (500 ml) will only be given in the rare occurrence of electrical activity of exceptionally long cross-clamp times more than 90 min. 39
Control Group Conventional blood crystalloid cardioplegia The heart is arrested with an induction dose (1 L) given over 1-2 min with pressure 100-200 mmHg. An additional dose is given at 30 min intervals till the time of removal of cross clamp. Cardioplegia solution is prepared as follows: For each 1000 ml Ringer’s solution: - Potassium chloride 2mEq/ml 30 mEq - Magnesium sulfate (10%) 10 ml (1gm) - Lidocaine (2%) 10 ml - Sodium Bicarbonate (8.4%) 1 mEq/ml 10 ml And will be given at a temperature 2-6 °C - Crystalloid: Blood ratio 3:2 The heart will be arrested with an induction dose (1 liter) of the conventional blood/crystalloid solution using ante grade delivery. In addition, repeated doses of the cardioplegia solution (500 ml) will be given through the ante grade cannula at 30 min intervals. 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 18 years or older Undergoing elective cardiothoracic surgical procedures requiring cardiopulmonary bypass with cross clamp time < 90 min Patient refusal Known allergy to any of the medications used in this study Patients with coronary artery diseases Patients with ejection fraction < 50% Emergency surgeries Patients on preoperative inotropic support and/or mechanical circulatory support Redo surgeries Adult: 19 Year-44 Year,Aged: 65+ 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 02/11/2020 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy Street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The rhythm after removal of aortic cross clamp After the removal of the aortic cross clamp
Secondary Outcome Reperfusion rhythm after removal of cross clamp After removal of the cross clamp
Secondary Outcome Potassium level immediately after aortic declamping Immediately after aortic declamping
Secondary Outcome The number and the dose of DC shocks During the operation.
Secondary Outcome CK, CKMB and Troponin T immediately after declamping. Immediately after declamping
Secondary Outcome Need for inotropes or vasopressor support and doses. Post cardiopulmonary bypass
Secondary Outcome Need for anti-arrhythmia medication. Post cardiopulmonary bypass
Secondary Outcome Ventricular ejection fraction change Post cardiopulmonary bypass
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Teaching Hospital Kasr Al Ainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tarek Marei Kasr Al Ainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospitals Kasr Al Ainy Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tarek Marei taamarei@gmail.com 00201281018888 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Intensive Care and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Radwa Osman radwa.s.osman@gmail.com 00201141595674 Ramsis Street
City Postal code Country Position/Affiliation
Cairo Egypt Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Radwa Osman radwa.s.osman@gmail.com 00201141595674 Ramsis Street
City Postal code Country Position/Affiliation
Cairo Egypt Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We can share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request, beginning 6 months and ending 24 months following article publication. Study Protocol From 6 to 24 months after article publication. Data will be accessible on reasonable request through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
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