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.: PACTR202106565996138 Date of Approval: 07/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Hemodynamic Effects of Inhaled Milrinone versus Inhaled Nitroglycerin
Official scientific title Study of the Acute Hemodynamic Effects of Inhaled Milrinone versus Inhaled Nitroglycerin on Mechanically Ventilated Patients with Pulmonary Hypertension after Mitral Valve Replacement Surgeries.
Brief summary describing the background and objectives of the trial Pulmonary hypertension (PH) is a usual complication of long-standing mitral valve disease. Perioperative pulmonary hypertension is a risk factor for right ventricular failure and is an important cause of morbidity and mortality in patients with pulmonary hypertension undergoing mitral valve surgery. . The aim of the study is to compare the effects of inhaled milrinone and inhaled nitroglycerin on pulmonary artery pressure and on the systemic hemodynamics in patients with pulmonary hypertension undergoing mitral valve surgery.
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,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 22/05/2021
Actual trial start date 22/05/2021
Anticipated date of last follow up 22/06/2021
Actual Last follow-up date 22/06/2021
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
FWA 000017585 Research ethical committee, Faculty of medicine, Ain Shams University
FWA 000017585 Research Ethics Committee, Faculty of Medicine, Ain Shams University
FWA 000017585 Research Ethical Committee, Faculty of medicine, Ain Shams Univerisity
FWA 000017585 Research Ethics Committee, Faculty of Medicine, Ain Shams University
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group A patients will receive inhaled milrinone (50µ/kg) over 15 mints through jet nebulizer (one side connected to inspiratory limb of the ventilator circuit just proximal to the endotracheal tube and the other side connected to nebulization port of the ventilator) immediately after arrival from the operating room. 20 Active-Treatment of Control Group
Experimental Group Group B patients will receive inhaled nitroglycerin (50µ/kg) over15 min through jet nebulizer (one side connected to inspiratory limb of the ventilator circuit just proximal to the endotracheal tube and the other side connected to nebulization port of the ventilator) immediately after arrival from the operating room. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
● Age between 18-65 years old. ● Patients with preoperative mitral valve disease (isolated mitral stenosis, regurgitation or combined stenosis and regurgitation) with pulmonary hypertension (mean pulmonary arterial pressure > 40 mmHg) admitted to postoperative ICU after already performed elective mitral valve replacement surgery. ● Both genders. ● Left ventricular ejection fractions over 40%. ● Patient undergoing emergency surgery. ● Redo surgeries. ● History of chronic obstructive pulmonary disease, severe renal disease, liver dysfunction, coagulopathy or thrombocytopenia. ● Patients with thromboembolic disease treated with anticoagulation therapy. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 18/11/2020 Research Ethics Committee REC
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Ain Shams University, Abbasia, Cairo, Egypt. Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome o Hemodynamic parameters including: heart rate, systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, central venous pressure, systolic pulmonary artery pressure, diastolic pulmonary artery pressure, mean pulmonary artery pressure, ejection fraction and fractional shortening. 5-10 minutes after arrival from the operating room, 5-10 minutes after the end inhalation and 5-10 minutes before extubation.
Secondary Outcome o Arterial and central venous blood samples will be obtained during each assessment point and immediately analyzed and arterial oxygen tension/fraction of inspired oxygen (PaO2/FiO2) ratio will be calculated by standard formulas. 5-10 minutes after arrival from the operating room, 5-10 minutes after the end inhalation and 5-10 minutes before extubation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Heart Institute Agouza Giza Egypt
Faculty of Medicine Ain Shams University Ramsis Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sherif Sayed Ali Sultan Abbasia Cairo Egypt
Ahmed Sarhan Farag Saeed Abbasia Cairo Egypt
Wafaa El Sayed Ismael Mostafa Abbasia Cairo Egypt
Paula Micheal El Komos Samaan Abbasia Cairo Egypt
Ahmed Kamel Abdel Ghany Hassan Abbasia Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Ain shams university Ramsis St. Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Sarhan Farag Saeed Cairo Cairo Egypt
Wafaa El Sayed Ismael Mostafa Cairo Cairo Egypt
Paula Micheal El Komos Samaan Cairo Cairo Egypt
Ahmed Kamel Abdel Ghany Hassan Cairo Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Sultan sherif_sultan@yahoo.com 00201128448448 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Professor at department of Anesthesia Intensive Care and Pain Management Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Sherif Sultan sherif_sultan@yahoo.com 00201128448448 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Professor at department of Anesthesia Intensive Care and Pain Management Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Sherif Sultan sherif_sultan@yahoo.com 00201128448448 Nasr Ciry
City Postal code Country Position/Affiliation
Cairo Egypt Professor at department of Anesthesia Intensive Care and Pain Management Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results Statistical Analysis Plan 6 months after publication internet search by keywords
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