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.: PACTR201911571076749 Date of Registration: 18/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The perioperative outcome of inhaled and intravenous levosimendan in children with pulmonary hypertension undergoing on pump cardiac surgery: a comparative randomized study
Official scientific title The perioperative outcome of inhaled and intravenous levosimendan in children with pulmonary hypertension undergoing on pump cardiac surgery: a comparative randomized study
Brief summary describing the background and objectives of the trial Pulmonary arterial hypertension in children is defined as mean pulmonary artery pressure (mPAP) more than 25 mmHg, it is a frequent condition that complicates cardiac surgery, and affects its outcome. Pulmonary arterial hypertension (PAH) is a common finding in children with left to right shunts. Closure of large left to right cardiac shunts and the use of cardiopulmonary bypass (CPB) in pediatric patents with pre existing PAH may cause an acute increase in pulmonary artery pressure leading to right ventricular dysfunction that increase the risk of in postoperative morbidity and mortality. Levosimendan (LS) is a calcium sensitizing agent that is considered a new class of inotropic drugs with vasodilator properties. It does not increase the intracellular concentration of free calcium. Infusion of LS increases cardiac output with a fall in pulmonary capillary wedge pressure. It improves cardiac function and survival in perioperative setting and in critical care patients. In fact a single infusion of LS in heart failure in adults have an effect lasting for 6-24 hours and result in hemodynamic changes, symptomatic benefits and reduction in mortality and morbidity. The use of intravenous infusion of levosimendan during cardiac surgery in patients with severe pulmonary hypertension has been shown to reduce pulmonary artery pressure (PAP) and decrease RV afterload. Inhaled levosimendan is a selective pulmonary vasodilator. It causes decrease in pulmonary artery pressure and improvement in right ventricular function, without having a significant effect on systemic vascular resistance (SVR). The aim of the current study is to compare the efficacy of inhaled versus intravenous levosimendan in controlling PAH in children submitted for total correction of congenital heart diseases (CHDs).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2019
Actual trial start date 01/12/2019
Anticipated date of last follow up 01/12/2020
Actual Last follow-up date 24/12/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL https://doi.org/10.1016/j.jclinane.2021.110231
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group patients will not receive levosimendan. The patients will receive normal saline by inhalation The patient will receive 3 ml normal saline by inhalation every 6 hours after weaning from CPB for 24 hours for 24 hours after weaning from CPB Patients will receive 3 ml normal saline by inhalation using simple jet nebulizer attached to the inspiratory limb of anesthesia ventilator close to the endotracheal tube immediately after weaning from CPB. 20 Placebo
Experimental Group Intravenous Group patients will receive intravenous infusion of levosimendan immediately after weaning from CPB for 24 h at 0.1 mcg/kg/min For 24 hours after weaning from CPB patients will receive intravenous infusion of levosimendan immediately after weaning from CPB for 24 h at 0.1 mcg/kg/min 20
Experimental Group Inhalation Group Total dose of levosimendan which will be given through intravenous route over 24 h at 0.1 mcg/kg/min will be calculated and then divided into four equal parts and will be administered 6th hourly by inhalation over 24 h. for 24 hours after weaning from CPB patients will receive levosimendan by inhalation using simple jet nebulizer attached to the inspiratory limb of anesthesia ventilator close to the endotracheal tube immediately after weaning from CPB. Total dose of levosimendan which will be given through intravenous route over 24 h at 0.1 mcg/kg/min will be calculated and then divided into four equal parts and will be administered 6th hourly by inhalation over 24 h. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Age from 1 to 10 years 2-on pump elective correction of congenital heart diseases 3- pulmonary arterial hypertension 1-refusal of the patients guardians 2- contraindication to use TEE 3-redo cardiac surgery 4-coagulation disorders 5-renal, hepatic or pulmonary disease 6-heart failure, Eisenmenger syndrome or right to left shunts and hypersensitivity of any of the studied drugs. Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 10 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 09/11/2019 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 assessment of intra and post-operative systolic PAP intra and post-operative systolic
Secondary Outcome 1. Heart rate(Hr) 2. Mean arterial pressure (MAP). 3. Central venous pressure (CVP). 4. Stroke volume (SV) using TEE 5. Cardiac output (CO) using TEE. 6. Ejection fraction (EF) using TEE. 7. Fraction shortening (FS) using TEE. 8. Respiratory parameters (SPO2, PaO2 and PaCO2). 9. Vasopressors (epinephrine and norepinephrine). 10. Urine output 11. Fluid and blood requirements intra and postoperative. 12. Time to wean from mechanical ventilation. 13. Duration of ICU stay 14. Time of hospital stay intra and post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ibrahim Abd Elbaser 2 El-Gomhouria 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 Street Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
Nabil Abd El raouf Abd El mageed 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abd Elbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at Mansoura University
Role Name Email Phone Street address
Public Enquiries Nabil Abd Elraouf nabil_abdelraouf@yahoo.com +20100491538648 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of anesthesia and surgical Intensive care
Role Name Email Phone Street address
Scientific Enquiries Hani Taman hani_taman@yahoo.com +201008288242 2- EL Gomhouria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia and surgical intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will individual participate data and share it through the PubMed indexed journal Informed Consent Form,Study Protocol Beginning 6 months and ending 12 months following article publication We will individual participate data and share it through the PubMed indexed journal
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