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Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension Due to Left Heart Disease

Status

Recruiting

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Milrinone inhalation

Milrinone infusion

About this trial

This is an interventional supportive care trial for Pulmonary Hypertension Due to Left Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients scheduled to undergo mitral valve surgery by cardiopulmonary bypass with estimated mean pulmonary artery pressure =>55 estimated by using preoperative Doppler echocardiography

Exclusion Criteria:

Patients were excluded if they had surgery without CPB, preoperative hemodynamic instability (deﬁned as acute requirement for vasoactive support or mechanical device),Patients with severe LV dysfunction (LV ejection fraction of less than 30% congenital heart disease, a contraindication to transesophageal echocardiography (TEE), emergency surgery or re-do surgeries severe renal or hepatic disease

, coagulopathy, and thromboembolic disease treated with anticoagulants

Sites / Locations

Zagazig UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group IH(inhaled milrinone)

Group Iv(Intravenous milrinone)

Arm Description

After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered

After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered

Outcomes

Primary Outcome Measures

mean arterial pressure

The effect of inhaled milrinone on mean arterial pressure is compared with the effect of intravenous milrinone

Secondary Outcome Measures

mean pulmonary arterial pressure

The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone

systemic vascular resistance

The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone

pulmonary vascular resistance

The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone

Full Information

NCT ID

NCT04484675

First Posted

July 13, 2020

Last Updated

January 3, 2023

Sponsor

Zagazig University

1. Study Identification

Unique Protocol Identification Number

NCT04484675

Brief Title

Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

Official Title

Comparative Study Between Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension Undergoing Cardiac Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 20, 2022 (Actual)

Primary Completion Date

February 1, 2023 (Anticipated)

Study Completion Date

February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery

Detailed Description

Milrinone is widely used in cardiac surgery as an inotrope and pulmonary vasodilator agent But , intravenous milrinone has been associated with systemic hypotension and increased requirement for vasoactive drugs The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Hypertension Due to Left Heart Disease

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.

Allocation

Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group IH(inhaled milrinone)

Arm Type

Active Comparator

Arm Description

After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered

Arm Title

Group Iv(Intravenous milrinone)

Arm Type

Active Comparator

Arm Description

After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered

Intervention Type

Drug

Intervention Name(s)

Milrinone inhalation

Other Intervention Name(s)

primacor

Intervention Description

After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered

Intervention Type

Drug

Intervention Name(s)

Milrinone infusion

Other Intervention Name(s)

primacor

Intervention Description

After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered

Primary Outcome Measure Information:

Title

mean arterial pressure

Description

The effect of inhaled milrinone on mean arterial pressure is compared with the effect of intravenous milrinone

Time Frame

change in mean arterial pressure is recorded 10 minutes after milrinone administration after induction (T1), at the end of nebulization (T2), before cardiopulmonary bypass (T3) and after cardiopulmonary bypass(T4)

Secondary Outcome Measure Information:

Title

mean pulmonary arterial pressure

Description

The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone

Time Frame

change in mean pulmonary arterial pressure 10 minutes after milrinone administration

Title

systemic vascular resistance

Description

The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone

Time Frame

change in systemic vascular resistance 10 minutes after milrinone administration

Title

pulmonary vascular resistance

Description

The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone

Time Frame

change in pulmonary vascular resistance 10 minutes after milrinone administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients scheduled to undergo mitral valve surgery by cardiopulmonary bypass with estimated mean pulmonary artery pressure =>55 estimated by using preoperative Doppler echocardiography Exclusion Criteria: Patients were excluded if they had surgery without CPB, preoperative hemodynamic instability (deﬁned as acute requirement for vasoactive support or mechanical device),Patients with severe LV dysfunction (LV ejection fraction of less than 30% congenital heart disease, a contraindication to transesophageal echocardiography (TEE), emergency surgery or re-do surgeries severe renal or hepatic disease , coagulopathy, and thromboembolic disease treated with anticoagulants

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Heba M EL-Asser, MD

Phone

01062393152

aseelaswad1@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Amany S abdelazeem, MD

Phone

01287220016

dola.salah2009@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heba M EL-Asser, MD

Organizational Affiliation

Zagazig University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zagazig University

City

Zagazig

State/Province

Sharkia

ZIP/Postal Code

44519

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heba M Elasser, MD

Phone

01062393152

aseelaswad1@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27470232

Citation

Denault AY, Bussieres JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQN, Varin F, Fortier A, Levesque S, Shi Y, Elmi-Sarabi M, Tardif JC, Perrault LP, Lambert J. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients. Can J Anaesth. 2016 Oct;63(10):1140-1153. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28.

Results Reference

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PubMed Identifier

19381522

Citation

Wang H, Gong M, Zhou B, Dai A. Comparison of inhaled and intravenous milrinone in patients with pulmonary hypertension undergoing mitral valve surgery. Adv Ther. 2009 Apr;26(4):462-8. doi: 10.1007/s12325-009-0019-4. Epub 2009 Apr 16.

Results Reference

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Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

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