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.: PACTR202109777317416 Date of Approval: 28/09/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Myocardial Protection With Histidine-Tryptophan- Ketoglutarate (HTK) Solution in Comparison With Hypothermic Hyperkalemic Blood (HHB) Solution in The Correction of Acyanotic Congenital Heart Diseases.
Official scientific title Myocardial Protection With Histidine-Tryptophan- Ketoglutarate (HTK) Solution in Comparison With Hypothermic Hyperkalemic Blood (HHB) Solution in The Correction of Acyanotic Congenital Heart Diseases.
Brief summary describing the background and objectives of the trial The myocardial protection methods are always an area of great researches and analysis. Enquiries about the best solutions, frequency of administration and optimum temperatures remain debateful. In 1970, one of the most widely used formulations was developed, Histidine-tryptophane-ketoglutarate solution or “HTK”, known in the market as Custodiol. The objective of this study is to compare the efficacy of two cardioplegic solutions used for myocardial protection in two groups of children submitted to surgical correctionofAcyanotic congenital cardiac defects using Histidine-Tryptophan- Ketoglutarate (HTK) versus hypothermic hyperkalemic blood (HHB) solution.
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 16/02/2020
Actual trial start date 16/02/2020
Anticipated date of last follow up 15/02/2021
Actual Last follow-up date 15/02/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group HTK administered as a single dose of 30 ml/kg infusion over 6-8 minutes. infusion over 6-8 minutes. Patients will receive the cold Histidine-tryptophan-ketoglutarate (HTK) solution (4-8°C), administered as a single dose for up to 3 hours of ischemia, antegrade in the aortic root after clamping of the aorta, for 6-8 minutes, with an infusion of 30 mL/kg. 30 Active-Treatment of Control Group
Experimental Group Group HHB Initial dose: 30 ml/kg repeated subsequent doses of 15 ml/kg every 20-25 minutes interval. Infusion over 4-5 minutes, every 20-25 minutes intervals. Patients will receive the Hypothermic Hyperkalemic Blood (HHB) solution; The crystalloid solution is obtained by adding 15 ml of 15% KCL (30 mEq), 25 ml of 8.4% NaHCO3 (25 mEq), and 5ml of 2% lidocaine (100 mg) to a 1L Ringer´s Lactate. A blood cardioplegia circuit will be added to the cardiopulmonary bypass machine. The perfusionist will add 60 mEq KCL to the crystalloid solution via using the cardioplegia delivery system. The HHB cardioplegia will be given by the perfusionist on CPB with a heat exchanger as the temperature will be regulated to 4°C and pressure control (up to 200 mmHg prior to the heat exchanger). The dilution ratio is a 4:1(4 parts autologous blood to 1 part crystalloid) mixture. The cardioplegia delivery technique will be: a 30 ml/kg dose of cardioplegia solution will be initially administered into the aortic root after clamping of the aorta for 4–5 min, followed by repeated doses of (15 ml/kg) at 20–25 min intervals using the same pattern. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Acyanotic congenital heart diseases undergoing total repair under cardiopulmonary bypass. Aged from 6 months to 2 years of both sexes. Scheduled for elective operations. Reoperation. Scheduled for palliative surgeries. Undergoing emergency surgeries. Patients with reduced left ventricular function, determined by left ventricular ejection fraction less than 40%. Patients with renal or liver impairment, determined by elevated creatinine levels or liver enzymes ‘AST and ALT’ more than normal values for age. Patients with any neurological dysfunction as epilepsy and cerebral palsy (CP). Infant: 1 Month-23 Month 6 Month(s) 24 Month(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 16/02/2020 Research Ethics Committee at Faculty of medicine Ain Shams university
Ethics Committee Address
Street address City Postal code Country
Ramsis street, Abbassia square Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Level of Troponins Measured preoperatively, after weaning from cardiopulmonary bypass at 0 hour, after 4, 8, 12, 18, 24, 48 hours postoperatively.
Secondary Outcome The left ventricular ejection fraction (EF %). Measured preoperatively, postoperatively after weaning from Cardiopulmonary Bypass at 0 hour, at 24 hours postoperatively, at 48 hours postoperatively
Secondary Outcome The left ventricular fractional shortening FS. Measured preoperatively, after weaning from cardiopulmonary bypass at 0 hour postoperatively, at 24 hours postoperatively, at 48 hours postoperatively.
Secondary Outcome The maximum vasoactive inotropic score VIS. The VIS was calculated according to Gaies et al study as follows: VIS= dopamine dose (mcg/kg/min) + dobutamine dose (mcg/kg/min) + 100 x epinephrine dose (mcg/kg/min) +10 x milrinone dose (mcg/kg/min) + 10,000 x vasopressin dose (U/kg/min) + 100 x norepinephrine dose (mcg/kg/min) Calculated at 24 hours postoperatively and at 48 hours postoperatively.
Secondary Outcome ICU length of stay Measured in days till discharge or death.
Secondary Outcome Hospital length of stay Measured in days till discharge or death.
Secondary Outcome Incidence of prolonged postoperative mechanical ventilation. 24 hours postoperative.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine at Ain Shams University Ramsis street, Abbassia square Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Mohamed Ali Mohamed Ahmed El toob El Ramly Cairo 11765 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine at Ain Shams university Ramsis, Abbassia square Cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mohamed Ali Mohamed Ahmed dr.ahmedali.231088@med.asu.edu.eg +201000740618 Eltoob El Ramly, Nasr city
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Assistant lecturer of Anesthesiology at faculty of medicine
Role Name Email Phone Street address
Public Enquiries Ossama Mansour viced.research@med.asu.edu.eg +20224346344 Ramsis street
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Vice Dean of research committee at faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries Samar Soliman Dr_sm.md@hotmail.com +201006236494 Ramsis street
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Lecturer of anesthesiology at faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available. Study Protocol Not applicable. Not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 02/01/2023 20/08/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 02/01/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://doi.org/10.1186/s42077-022-00260-z
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 02/01/2023 the paper has been published 20 Aug 2022
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results & Publication URL 02/01/2023 the paper has been published https://doi.org/10.1186/s42077-022-00260-z
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results & Publication URL 02/01/2023 the paper has been published https://trebuchet.public.springernature.app/get_content/ad7d2827-d439-40ae-8633-6f3add7772b9
Section Name Field Name Date Reason Old Value Updated Value
Reporting Link to protocol 02/01/2023 the paper has been published https://doi.org/10.1186/s42077-022-00260-z
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 02/01/2023 the paper has been published. No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 02/01/2023 this is the final paper published with the result 16154_11210_1045.pdf