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.: PACTR202209903019732 Date of Approval: 02/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Bosentan and Sildenafil in Pulmonary Hypertension in Cardiac Anesthesia
Official scientific title Bosentan and Sildenafil in Pulmonary Hypertension in Cardiac Anesthesia: Mansoura Novel Strategy
Brief summary describing the background and objectives of the trial Cardiac surgical patients presenting with pre-existing pulmonary hypertension (PHTN) are at a higher risk for postoperative complications. Accurate preoperative assessment and diligent anesthetic management are crucial for the best outcome. In the periperative period, treatment of PHTN is challenging and usually includes sedation, maintaining low partial pressure of carbon dioxide in arterial blood by hyperventilation, and the use of pulmonary vasodilators. Bosentan, an orally active non-peptide endothelin receptor antagonist of ET- A and ET-B, has been shown to decrease inflammatory reactions, vasoconstriction and development of fibrosis in pulmonary vessels. This study hypothesizes that perioperative combined use of sildenafil and bosentan in adults with moderate to severe pulmonary hypertension due to mitral valve disease will affect outcome of cardiac surgeries associated with PHTN compared to sildenafil alone
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
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/09/2022
Actual trial start date 15/09/2022
Anticipated date of last follow up 01/01/2023
Actual Last follow-up date 01/02/2023
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group S group Sildenafil group In the outpatient clinic, 20 participants will be randomly assigned to 20 mg sildenafil and placebo twice daily for 4-6 weeks preoperatively 4-6 weeks preoperatively In the outpatient clinic 20 mg sildenafil and placebo given twice daily for 4-6 weeks preoperatively to 20 patients 20 Placebo
Experimental Group SB group Sildenafil plus bosentan group 20 mg sildenafil twice daily plus bosentan 62.5 mg twice daily for 4-6 weeks unless drug related adverse events appear (hypotension or elevated liver enzymes > 2 folds) 4-6 weeks preoperatively 20 mg sildenafil twice daily plus bosentan 62.5 mg twice daily for 4-6 weeks given for 20 participants preoperatively 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.American Society of Anesthesiologists physical status grade II and ш. 2.Age between 20 and 70 years. 3.either gender. 4.Systolic pulmonary artery pressure greater than 70 mmHg. 1.Patient refusal. 2.Uncompensated cardiac disease. 3.Severe chronic obstructive pulmonary disease ( COPD) and bronchial asthma. 4.Chest infection. 5.uncontrolled HTN and DM. 6.Preoperative liver and renal disease. 7.Body Mass Index > 40 Kg/m2. 8.Hematologic disorders. 9.Neuromuscular disorders. Redo and urgent surgeries. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 70 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 06/11/2021 IRB Mansoura faculty of medicine
Ethics Committee Address
Street address City Postal code Country
El Gomhoria street Mansoura MD2110538 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Systolic Pulmonary artery pressure, Pulmonary vascular resistance, Tricuspid annular plane systolic excursion (TAPSE), intraoperative by transesophageal echo before cardiopulmonary bypass
Secondary Outcome Heart rate, MAP, pulse oximetry Cross Clamp time., Bypass time. Anaesthesia time.Duration of surgery. Vaso-active inotropic medications Heart rate, MAP, pulse oximetry, recorded after induction, every 30 min during surgery till closure of the sternum
Secondary Outcome CRP, RBG laboratory assessment CRP : immediately on arrival to ICU and was repeated at 24h and 48h postoperative. RBG : immediately on arrival to ICU and repeated every 6 hours in 1st 24 hour postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cardiothoracic and vascular surgery cente Mansoura university hospitals El Gomhoria street Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura university Elgomhoria Street Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university Elgomhoria street Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Nabil Badr Eldin Mahmoudbadr91@gmail.om 00201069880644 elgomhoria street
City Postal code Country Position/Affiliation
mansoura Egypt Mahmoud N. Badr Eldin
Role Name Email Phone Street address
Scientific Enquiries Magdy Mamdouh attallah magdyata@gmail.com 00201006707776 Elgomhoria
City Postal code Country Position/Affiliation
mansoura Egypt Magdy M.Attallah
Role Name Email Phone Street address
Public Enquiries Ola Taha Abdeldayem olataha2007@yahoo.com 00201202811110 elgomhoria street
City Postal code Country Position/Affiliation
mansoura Egypt Ola T. Abdeldayem
Role Name Email Phone Street address
Public Enquiries Naglaa Abdelatief ElNegeery naglaaelnegeery@gmail.com 02001006198288 elgomhoria street
City Postal code Country Position/Affiliation
Mansoura Egypt Elnegeery N.A.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes any researcher covered by ethical committee or institutional review board can share data within 12 months of study completion date Statistical Analysis Plan,Study Protocol data can be shared as requested by a researcher covered by ethical committee or instituitional review board controlled
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