NCT07416331

Impact Of Using LevosemidanVersus DobutamineOn Right Ventricular Function In AdultPatients Undergoing Elective Valve Replacement Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Helwan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

in this prospective, randomized, controlled double blinded study conducted at Helwan University Hospitals include 52 patients with rheumatic mitral and/or aortic valve disease and pulmonary arterial hypertension at the start of rewarming, patients will be randomly assigned into either group 1 (levosimendan) or group 2 (dobutamine ) Group 1 patients will receive dobutamine, 3-5 microgram/kg group 2 patients will receive levosimendan 6 ug/kg bolus over 10 minutes, followed by infusion at a rate of 0.1 mg/kg/min Transthoracic echocardiography performed before induction of anaesthesia (baseline), 6 and 12 hours post surgery . In addition, transthoracic echocardiography also performed 24 hours post extubating. Transoesophageal echocardiography (TEE) examination performed during the intraoperative period before the initiation of CPB (pre CPB) and 30 minutes after separation from CPB (post-CPB) Echocardiographic parameters measured will include tricuspid annular plane systolic excursion (TAPSE), Tei index and myocardial systolic velocities at the tricuspid annulus (S/) for the assessment of right ventricular systolic function, and ratio of tricuspid inflow to tricuspid annular diastolic velocity (E/E/) for the assessment of right ventricular diastolic function. Pulmonary artery pressure will be assessed frequently by transthoracic echo during every assessment.

Conditions

• Right Ventriculaire Dysfunction
• Pulmonary Hypertension

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: Egypt