PGI2 Versus Nitroglycerine for Management of Pulmonary Hypertension After Valve Surgeries

NCT04594629 | Unknown Phase 1

• 1 other identifier: FMASU R 70/2020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

PGI2; Nitroglycerine; valve replacement surgery; pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• mean pulmonary artery pressure

  decrease of mean pulmonary artery pressure

  baseline, 30 minutes after start of study drug, 4 hours after start of study drug

Secondary Outcomes (2)

• mortality

  30 days postoperative

• central venous pressure

  at the end of cardiopulmonary bypass (baseline values) then 30 minutes after start of treatment then 4 hours after start of treatment

Study Arms (2)

nitroglycerine group

SHAM COMPARATOR

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

Drug: Nitroglycerin

PGI2 group

ACTIVE COMPARATOR

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.

Drug: PGI2

Interventions

Nitroglycerin DRUG

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

Also known as: N group

nitroglycerine group

PGI2 DRUG

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

Also known as: PG group

PGI2 group

Eligibility Criteria

• Age: 54 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 66 years old
• elective valve replacement surgery
• pulmonary arterial hypertension

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Study Officials

• Ayman Shoeb

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Hoda Shokri

CONTACT

01211179234; drhoda10@yahoo.com

Ihab Ali

CONTACT

01279410660; drihababdelrazek@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anaesthesiology

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 20, 2020
• Study Start: November 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 5-6 months
• Access Criteria: The collected data are coded, tabulated, and statistically analyzed using statistical package for social sciences software, version 17.0 (SPSS Inc., Chicago, Illinois, USA). Descriptive statistics are carried out for numerical parametric data and presented as mean±SD, whereas categorical data are presented as number and percentage. Variables such as demographic data and comorbidities are compared using the χ2-test. A P value less than 0.05 was considered significant.

Locations

EG (1)