NCT04484675

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
2.8 years until next milestone

Study Start

First participant enrolled

May 20, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

July 13, 2020

Last Update Submit

April 26, 2025

Conditions

Pulmonary Hypertension Due to Left Heart Disease

Outcome Measures

Primary Outcomes (1)

  • mean arterial pressure

    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 Outcomes (3)

  • mean pulmonary arterial pressure

    change in mean pulmonary arterial pressure 10 minutes after milrinone administration

  • systemic vascular resistance

    change in systemic vascular resistance 10 minutes after milrinone administration

  • pulmonary vascular resistance

    change in pulmonary vascular resistance 10 minutes after milrinone administration

Study Arms (2)

Group IH(inhaled milrinone)

ACTIVE COMPARATOR

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

Group Iv(Intravenous milrinone)

ACTIVE COMPARATOR

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

Interventions

Milrinone inhalationDRUG

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

Also known as: primacor
Group IH(inhaled milrinone)
Milrinone infusionDRUG

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

Also known as: primacor
Group Iv(Intravenous milrinone)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

RECRUITING

Related Publications (2)

  • 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.

    PMID: 27470232BACKGROUND

  • 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.

    PMID: 19381522BACKGROUND

MeSH Terms

Interventions

Milrinone

Intervention Hierarchy (Ancestors)

AmrinoneAminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Heba M EL-Asser, MD

    Zagazig University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heba M EL-Asser, MD

CONTACT

01062393152aseelaswad1@yahoo.com

Amany S abdelazeem, MD

CONTACT

01287220016dola.salah2009@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 23, 2020

Study Start

May 20, 2023

Primary Completion

May 10, 2025

Study Completion

May 10, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)