Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

January 3, 2023 updated by: Heba Mohamed EL -Asser,MD, Zagazig University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Recruiting
        • Zagazig University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group IH(inhaled milrinone)
After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered
Drug: Milrinone inhalation
After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered
Other Names:
  • primacor
Active Comparator: Group Iv(Intravenous milrinone)
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
Drug: Milrinone infusion
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
Other Names:
  • primacor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean arterial pressure
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)
The effect of inhaled milrinone on mean arterial pressure is compared with the effect of intravenous milrinone
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 Measures

Outcome Measure
Measure Description
Time Frame
mean pulmonary arterial pressure
Time Frame: change in mean pulmonary arterial pressure 10 minutes after milrinone administration
The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone
change in mean pulmonary arterial pressure 10 minutes after milrinone administration
systemic vascular resistance
Time Frame: change in systemic vascular resistance 10 minutes after milrinone administration
The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone
change in systemic vascular resistance 10 minutes after milrinone administration
pulmonary vascular resistance
Time Frame: change in pulmonary vascular resistance 10 minutes after milrinone administration
The effect of inhaled milrinone on mean pulmonary pressure is compared with the effect of intravenous milrinone
change in pulmonary vascular resistance 10 minutes after milrinone administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • milrinone in cardiadc surgery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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