Efficacy of Nebulized PGI2 Versus Nebulized Nitroglycerine for Management of Pulmonary Hypertension After Valve Replacement Surgeries

NCT04594629 Phase 1 UNKNOWN

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.

Details

Lead sponsor	Ain Shams University
Phase	Phase 1
Status	UNKNOWN
Enrolment	120
Start date	2020-11
Completion	2021-06

Conditions

• Pulmonary Hypertension

Interventions

• Nitroglycerin
• PGI2

Primary outcomes

• mean pulmonary artery pressure — baseline, 30 minutes after start of study drug, 4 hours after start of study drug
  decrease of mean pulmonary artery pressure

Countries

Egypt