PGI2 Versus Nitroglycerine for Management of Pulmonary Hypertension After Valve Surgeries

Ain Shams University

Status and phase: Unknown; Phase 1

Conditions: Pulmonary Hypertension

Treatments: Drug: PGI2; Drug: Nitroglycerin

Study type: Interventional

Funder types: Other

Identifiers

NCT04594629

FMASU R 70/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 54 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

nitroglycerine group

Sham Comparator group

Description:

Patients of nitroglycerine group received nebulized nitro glycerine (a vial contains 50 mg nitroclycerine ), its starting concentration was 200 mcg/ml with nitro glycerine was delivered at 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

Treatment:

Drug: Nitroglycerin

PGI2 group

Active Comparator group

Description:

Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (Flolan; Glaxo Wellcome Inc, Research Triangle Park, NC) (60 ml syringe of PGI2 with concentration 20000 ng/ml was attached to an intravenous pump which delivers a titrating rate of 8 ml/h to the nebulizer compartment (MiniHEART nebulizer; Westmed, Tucson, Ariz) fixed to the inspiratory limb of the breathing circuit or to the face mask with venturi accessory for sprinkling. The nebulizer was filled with 15 ml PGI2 with nebulized oxygen flow rate 3 litres.

Treatment:

Drug: PGI2