Clinical trial NCT04594629: PGI2 Versus Nitroglycerine for Management of Pulmonary Hypertension After Valve Surgeries
Official title: Efficacy of Nebulized PGI2 Versus Nebulized Nitroglycerine for Management of Pulmonary Hypertension After Valve Replacement Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pulmonary Hypertension
Keywords: PGI2
Nitroglycerine
valve replacement surgery
pulmonary hypertension
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 120
Sex: ALL
Minimum age (years): 54
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Postoperative pulmonary hypertension (PHT) is the most challenging complication of valvular heart disease about 73% of the patients particularly in those posted for mitral valve replacement surgery Methods This prospective study was conducted in 120 patients aged from 54-65 years scheduled for elective valve replacement surgeries. Patients were randomly allocated to either nitro glycerine or PGI2 groups. Patients of nitro glycerine group received nebulized nitro glycerine (its starting concentration was 200 mcg/ml); nitro glycerine was delivered at a rate of 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser connected to the inspiratory limb of the breathing circuit. 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 to the nebulizer compartment. 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) measured at the end of cardiopulmonary bypass then 30 minutes after start of treatment then 4 hours after start of treatment, 30-day mortality rate and the incidence of complications such as facial flushing, hypotension and re-exploration for bleeding.

Eligibility criteria: Inclusion Criteria:

* 35 to 66 years old
* elective valve replacement surgery
* pulmonary arterial hypertension

Exclusion Criteria:

* Emergency surgery
* severe renal and hepatic dysfunction
* uncontrolled supraventricular arrhythmia
* those requiring preoperative inotropes

Primary outcomes:
measure: mean pulmonary artery pressure
timeFrame: baseline, 30 minutes after start of study drug, 4 hours after start of study drug
Secondary outcomes:
measure: mortality
timeFrame: 30 days postoperative
measure: central venous pressure
timeFrame: at the end of cardiopulmonary bypass (baseline values) then 30 minutes after start of treatment then 4 hours after start of treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
Study officials:
affiliation: Ain Shams University
name: Ayman Shoeb
role: STUDY_DIRECTOR
References: