drugset / Trial / NCT04594629

PGI2 Versus Nitroglycerine for Management of Pulmonary Hypertension After Valve Surgeries

NCT04594629

Phase 1 Unknown 120 enrolled Ain Shams University
RandomizedParallel-groupDouble-blindTreatment

Summary

This study was conducted in 120 patients aged from 54-65 years scheduled for elective valve replacement surgeries. Patients were randomly allocated to nitro glycerine or PGI2 groups. Patients of nitro glycerine group received nebulized nitro glycerine at a rate of 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser. Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (20000 ng/ml in 60 ml syringe was attached to an intravenous pump which delivers a titrating rate of 8 ml/h . The primary outcome was mean pulmonary artery pressure. The secondary outcomes included mean arterial blood pressure (MAP) (mmHg), PaO2/FiO2 ratio, cardiac index (CI) (l/min/m2) right ventricular ejection fraction (RVEF), central venous pressure(CVP) , 30-day mortality rate and the incidence of complications such as facial flushing, hypotension and re-exploration for bleeding.

Timeline

Start
2020-11
Primary completion
2021-05
Completion
2021-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nitroglycerin Unknown 2.5 ug/kg Inhaled
Comparator Nitroglycerin Unknown 5 ug/kg Inhaled
Comparator Nitroglycerin Unknown 200 ug/ml Inhaled
Comparator PGI2 Unknown 20000 ng/ml Inhaled