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.: PACTR202005520371433 Date of Approval: 08/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Hemodynamic effects of simultaneous infusion of Milrinone and Terlipressin in pediatric patients with pulmonary hypertension undergoing on pump cardiac surgery
Official scientific title Hemodynamic effects of simultaneous infusion of Milrinone and Terlipressin in pediatric patients with pulmonary hypertension undergoing on pump cardiac surgery
Brief summary describing the background and objectives of the trial Introduction: Pulmonary arterial hypertension (PAH) is a major complication in children with intracardiac and extracardiac shunts. Milrinone is well established inodilator which is extensively used to in cardiac surgery due to its beneficial effect on the pediatric heart and pulmonary vasculature especially on PAH caused by CHD. Usually, milrinone leads to systemic vascular hypotension at inotropic doses and requires the addition of a vasoconstrictive drug. Terlipressin is a long-acting synthetic analog vasopressin which has been reported to be effective in restoring the systemic arterial pressure after septic shock, intraoperative hypotension, postcardiotomy hypotension ,for milrinone-induced hypotension and in off-pump cardiac surgery patients.This prospective double –blind randomized study will be conducted on (75) pediatric patients of either sex aging from1-4 years, who will be planned to undergo elective correction of congenital heart diseases suffering from pulmonary hypertension using cardiopulmonary bypass. Patients and methods: Eligible 75 patients will be randomly allocated into 3 equal groups: • Terlipressin (T) group (n=25): terlipressin infusion at a dose of 2-5 μg/kg/h. • Norepinephrine (N) group (n=25): norepinephrine infusion at dose 0.05-0.2 ug/kg/min. • Placebo group (P) group (n=25). Each group will receive injection milrinone 50μg/kg of bolus dose over period of 10 minutes and then 0.5μg/kg/min infusion.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cardiology,Circulatory System,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2020
Actual trial start date 01/04/2020
Anticipated date of last follow up 30/04/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants)
Recruitment status 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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placepo group only receive injection milrinone 50μg/kg of bolus dose over period of 10 minutes and then 0.5μg/kg/min infusion 48 hours only receive injection milrinone 50μg/kg of bolus dose over period of 10 minutes and then 0.5μg/kg/min infusion 25 Placebo
Experimental Group Terlipressin simultaneously receive injection milrinone 50μg/kg of bolus dose over period of 10 minutes and then 0.5μg/kg/min infusion plus terlipressin infusion at a dose of 2-5 μg/kg/h. 48 hours simultaneously receive injection milrinone 50μg/kg of bolus dose over period of 10 minutes and then 0.5μg/kg/min infusion plus terlipressin infusion at a dose of 2-5 μg/kg/h. 25
Experimental Group norepinephrine simultaneously receive injection milrinone 50μg/kg of bolus dose over period of 10 minutes and then 0.5μg/kg/min infusion plus norepinephrine infusion at dose 0.05-0.2 ug/kg/min. 48 hours simultaneously receive injection milrinone 50μg/kg of bolus dose over period of 10 minutes and then 0.5μg/kg/min infusion plus norepinephrine infusion at dose 0.05-0.2 ug/kg/min. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study will be conducted on 75 patients of either sex with the following inclusion criteria 1. Age 1–4 years. 2. Elective corrective open heart surgery using cardiopulmonary bypass (CPB). 3. Congenital cardiac anomalies associated with pulmonary hypertension (PAH-CHD) with pulmonary artery pressure (PAP) more than 40 mmhg. 1. Patients with previous open heart surgery. 2. Neurological, renal or hepatic disease. 3. Decompensated heart failure. 4. Eisenmenger syndrome or right to left shunts. 5. Presence of preoperative coagulation disorders. 6. Contraindication to use TEE. 7. Hypersensitivity of any of the studied drugs. Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 4 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 04/03/2020 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El-Gomhouria Street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assess systolic pulmonary artery pressure in the intra-operative and 24 hours post-operative periods. basal, pre-CBP, during the weaning from CPB, and post-CPB period 10 minutes after protamine administration. After surgery in the postoperative period data will be recorded after 1h and 24 hours after
Secondary Outcome the patients' heart rate, blood pressure, TEE data, arterial blood gases tensions, time of extubation and ICU and hospital length of stays. basal, pre-CBP, during the weaning from CPB, and post-CPB period 10 minutes after protamine administration. After surgery in the postoperative period data will be recorded after 1h and 24 hours after
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital MUCH 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Ahmed Maher Ibrahim Elmorsy 2- EL gomhoria street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university children hospital 2 el gomhouria st Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Ahmed Maher Ibrahim Elmorsy 2 EL-Gomhouria st Mansoura 35516 Egypt
Ibrahim Ibrahim Abd Elbaser 2 EL Gomhouria st Mansoura 35516 Egypt
Nabil Abd El raouf Abd El mageed 2 EL Gomhouria st Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohames Elmorsy m.am.elmorsy@gmail.com +201112582480 2 EL Gomhouria st
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at faculty of medicine Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Abd elbaseer ibrahimbaser2010@yahoo.com +201004976825 2 EL Gomhouria st
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at faculty of medicine Mansoura University
Role Name Email Phone Street address
Public Enquiries Nabil Abdelraouf nabil_abdelraouf@yahoo.com +201001538648 2 EL Gomhouria st
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura universit
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Non identified patients data will be available in excel sheets with the principle investigator for 6 months after publication of the paper Informed Consent Form,Study Protocol Documents will be available within 6 months after publication of the paper. Open access to IPD to reviewers. Data will be send directly by email upon request. m.am.elmorsy@gmail.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://irb.mans.edu.eg 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