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.: PACTR202302881132303 Date of Approval: 22/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of Milrinone in the Prevention of Septic Myocardial Dysfunction in Pediatric Severe Sepsis and Septic Shock
Official scientific title Role of Milrinone in the Prevention of Septic Myocardial Dysfunction in Pediatric Severe Sepsis and Septic Shock
Brief summary describing the background and objectives of the trial Low cardiac output syndrome (LCOS) refers to a decrease in cardiac output related to transient myocardial dysfunction, as seen in patients who have various causes, including shock, and those who have undergone cardiac surgery. To prevent morbidity that is associated with poor systemic perfusion, early identification and prevention of this physiologic state and its consequences, and prompt management to maintain oxygen and nutrient supply to the peripheral tissues are essential. Milrinone is used in clinical practice since the early 1990s. It is nowadays the most frequently used drug to prevent postoperative LCOS in children after cardiac surgery in Europe. In the postoperative care of children and neonates after open-heart surgery, Milrinone has proved to be safe and shows an acute beneficial effect on hemodynamics; it improves cardiac index, decreases filling pressures, and decreases pulmonary vascular resistance. It has also been shown that Milrinone reduces the relative risk of a postoperative LCOS by as much as 64% and that there is a beneficial effect in the optimization of cardiovascular function in the acute setting in the pediatric age group.  Severe sepsis and septic shock in children are often characterized by a low cardiac output state as a consequence, so we need to prevent LCOS after resuscitation during the hospital stay, and there are limited studies to prove the role of Milrinone in the prevention of LCOS in pediatrics severe sepsis and septic shock. The aim of the current study is to evaluate the effect of Milrinone in improving myocardial function in children with severe sepsis and septic shock admitted to the Alexandria University Pediatric Intensive Care Unit.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/02/2023
Actual trial start date
Anticipated date of last follow up 14/02/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Milrinone Will be titrated Milrinone starting from 0.25 mic/kg/min till 0.75 mic/kg/min according to cardiac output Until the patient becomes hemodynamically stable for at least 8 hours Continuous intravenous infusion 20
Control Group Survival Sepsis Campaign Will be resuscitated according to Survival Sepsis Campaign Until the patient becomes hemodynamically stable for at least 8 hours Survival Sepsis Campaign 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Children with severe sepsis/septic shock after resuscitation according to pediatric 2020 surviving sepsis campaign international guidelines( SSC) - Children with a cardiac index of more than 2.2 l/min/m2. - Patients with primary myocardial diseases or congenital heart or chronic heart disease. - Patients with significant left ventricular outflow tract obstruction or the need for extracorporeal membrane oxygenation. - Patients receiving chemotherapeutic agents. Child: 6 Year-12 Year,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 1 Month(s) 12 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 15/12/2022 The Ethics Committee of the Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street El Messalah Alexandria Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Development of low cardiac output syndrome daily till 7 days
Primary Outcome Death First 72 hours after drug administration
Secondary Outcome Duration of Pediatric Intensive Care Unit stay Through out PICU stay
Secondary Outcome Duration of mechanical ventilation Through out PICU stay
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric Intensive Care Unit Alexandria University Children hospital Port saeed street El-Shatby Alexandria 21321 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Esraa Ali Metwally Smouha el nasr street grand ville compound Alexandria 21648 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric Department Alexandria University Port saeed street, El-Shatby Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Ahmed Sayed ElNawawy Port saeed street ElShatby Alexandria 21521 Egypt
Azza Ahmed Ahmed Moustafa Port saeed street ElShatby Alexandria 21521 Egypt
Hadir Mohamed Hassouna 9 serhank street louran elraml Alexandria 21532 Egypt
Esraa ali metwally Smouha el nasr street grand ville compound Alexandria 21648 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed ElNawawy Dr_anawawy@yahoo.com +2034837454 Port saeed street ElShatby
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor Pediatrics Faculty of Medicine Alexandria University Egypt
Role Name Email Phone Street address
Scientific Enquiries Azza Moustafa profdrazzamoustafa@alexmed.edu.eg +201008948826 Port saeed street ElShatby
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor Pediatrics Faculty of Medicine Alexandria 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. The 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