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.: PACTR202408668477631 Date of Approval: 13/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Association of Pulmonary Artery Systolic Pressure Measured by Transoesophageal Echocardiography with Early Postoperative Morbidity in Patients Undergoing Elective on Pump Coronary Artery Bypass Grafting
Official scientific title Association of Pulmonary Artery Systolic Pressure Measured by Transoesophageal Echocardiography with Early Postoperative Morbidity in Patients Undergoing Elective on Pump Coronary Artery Bypass Grafting
Brief summary describing the background and objectives of the trial The major complications associated with coronary artery bypass grafting (CABG) are death, myocardial infarction, stroke, wound infection, prolonged requirement for mechanical ventilation, acute kidney injury, and bleeding requiring transfusion or reoperation (Fortescue et al., 2001). In our study we will measure the association of pulmonary artery systolic pressure (PASP) measured intraoperative by transoesophageal echocardiography (TEE) with early postoperative morbidity in the elective on pump coronary artery bypass grafting (CABG) surgery.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/03/2022
Actual trial start date 25/03/2022
Anticipated date of last follow up 01/03/2024
Actual Last follow-up date 01/04/2024
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tee measure pulmonary artery systolic pressure and post operative complications . Till patient discharged from hospital Group A: we observe the postoperative complications in ICU in this group using the TEE measure of PASP intraoperative that in Group (A) PASP ≥35 mmhg (n=35) in patient undergoing CABG on pump 35
Control Group TEE measure pulmonary artery systolic pressure and postoperative complications . Till patient discharged from hospital In your study, the control group (Group B: PASP < 35 mmHg) consists of patients who do not have pulmonary hypertension as measured by intraoperative TEE. For this group, the "intervention" would likely involve standard perioperative care for patients undergoing elective on-pump coronary artery bypass grafting (CABG), without any additional measures specifically targeting pulmonary artery systolic pressure (PASP). So, the control group in this context is essentially receiving standard care without any special intervention for PASP, allowing you to compare outcomes between those with and without pulmonary hypertension. 35 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Patients who accept to participate in the study o Age group: 30-80 years old o Sex: both sex o Candidates for isolated elective CABG on cardiopulmonary bypass (CPB) pump o Patients who refuse to participate in the study. o Patients with significant right ventricular outflow tract obstruction. o Patients undergoing redo CABGs. o Patients with contraindications for the performance of TEE. o Patients with non-analyzable tricuspid regurge (TR) jet. o Patient scheduled for offpump CABGs, urgent CABGs, redo CABGs and combined valves CABGs o Severe pulmonary diseases causing elevation of pulmonary pressure as COPD, pulmonary fibrosis, and obstructive sleep apnea o Primary Pulmonary arterial hypertension (PAH) 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 80 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 25/01/2022 Research ethics committee faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38, Abbasia , Cairo , Egypt Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to assess if the elevation of PASP estimated intraoperative by TEE in patients undergoing elective CABG surgery, will be independently predictive of early postoperative complications and events as indicators for postoperative early morbidity in these patients. early postoperative complications after CABG at cardiothoracic ICU
Secondary Outcome identify the risk factors associated with such elevation of PASP. Early postoperative complications after CABG at cardiothoracic icu
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cardiothoracic hospital at Ain Shams University Hospitals Abbasia Cairo 020 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine Ain shams university Abbasia Cairo 202 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain shams university Abbasia Cairo 202 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mostafa Drahmed.mostafa.mohamed@med.asu.edu.eg 01121318459 Nasr city
City Postal code Country Position/Affiliation
Cairo 202 Egypt Academic supervisor
Role Name Email Phone Street address
Principal Investigator Assem Elders Dr.asemelders9@gmai.com 01552417606 Square 1
City Postal code Country Position/Affiliation
Tenth of Ramadan city 202 Egypt Main participant
Role Name Email Phone Street address
Public Enquiries Salwa Khattab Dr.salwakhattab@gmail.com 01221742262 Fifth statement
City Postal code Country Position/Affiliation
Cairo 202 Egypt Academic supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data (IPD) that underlie the results reported in this study will be shared in a deidentified format. This data will include: Demographic Information: Age, sex, ethnicity, etc. Clinical Characteristics: Baseline health status, comorbidities, and diagnostic test results, including measurements of pulmonary artery systolic pressure (PASP). Treatment Details: Type of intervention, dosage, frequency, duration, etc. Outcome Measures: Primary and secondary outcomes, adverse events, and follow-up results. The data will be deidentified to ensure participant privacy and will be available through a secure platform. Access to the IPD will be provided to qualified researchers upon request, and all data use will be governed by a data use agreement to protect confidentiality and restrict re-identification." This description focuses on the specifics of what will be shared and emphasizes the deidentification and secure access aspects to meet the requirements for IPD sharing. Study Protocol The individual participant data will be made available within 12 months of the study completion date, in compliance with regulatory requirements. Not applicable
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