NCT05132153

Brief Summary

The primary aim of this study was to investigate the effect inhaled milrinone given before CPB on improving the right ventricular function measured by transesophageal echocardiography (TEE) at time of CPB separation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 17, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

October 22, 2021

Last Update Submit

July 18, 2022

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Effect of inhaled milrinone on improvement of right ventricular function

    The right ventricle function will be assessed by Fractional area change ( Change in area between systole and diastole by echocardiograph ( intraoperative and postoperative)

    After 15 minutes of inhaled milrinone intraoperative and repeated after 12, 24 hours in intensive care unit

Study Arms (2)

(Group A) will receive milrinone

ACTIVE COMPARATOR

Patients will receive milrinone 50 microgram/kg in 5ml volume, over 5 min by nebulization

Drug: Milrinone

(Group B) will receive normal saline

PLACEBO COMPARATOR

Patients will receive 5 ml saline by nebulization over 5 min

Drug: Normal saline

Interventions

MilrinoneDRUG

will be given by nebulization

(Group A) will receive milrinone
Normal salineDRUG

will be given by nebuliztion

(Group B) will receive normal saline

Eligibility Criteria

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

You may not qualify if:

  • Cardiac surgery without CPB.
  • Hemodynamic instability in the preoperative time (defined as acute requirement for vasoactive support or mechanical device).
  • Adult congenital heart disease planned for corrective surgery.
  • Contraindication to transesophageal echocardiography (TEE).
  • Any surgery involves tricuspid valve annulus as it will compromise the accuracy of RV function assessment by TEE.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samar Soliman

Cairo, Nasr City, 11511, Egypt

RECRUITING

MeSH Terms

Interventions

MilrinoneSaline Solution

Intervention Hierarchy (Ancestors)

AmrinoneAminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Samar Soliman

CONTACT

01006236494dr_sm.md@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia

Study Record Dates

First Submitted

October 22, 2021

First Posted

November 24, 2021

Study Start

October 17, 2021

Primary Completion

September 1, 2022

Study Completion

September 20, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations

EG(1)