NCT06077721

Brief Summary

The purpose of this study is to analyze the changes in right ventricular strain before and after milrinone administration in order to find out whether milrinone improves RV systolic performance in patients undergoing cardiac surgery.

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
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

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

First Submitted

Initial submission to the registry

October 5, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

November 3, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

October 5, 2023

Last Update Submit

January 17, 2024

Conditions

Ischemic Heart DiseaseValvular Heart Disease

Keywords

Milrinonestrainsystolic function

Outcome Measures

Primary Outcomes (1)

  • 1. Right ventricular strain

    15 min after milrinone administration

Secondary Outcomes (2)

  • Left ventricular strain

    15 min after milrinone administration

  • Left ventricular ejection fraction

    15 min after milrinone administration

Interventions

MilrinoneDRUG

giving intravenous milrinone: 50 mcg/kg loading dose by IV push over 10 minutes, then 0.375-0.75 mcg/kg/ min infusion

Also known as: Milrinone intravenous administration

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

valvular heart disease, coronary heart disease

You may qualify if:

  • patient agree and provide written informed consent.
  • patient undergoing elective cardiac surgery
  • preoperative LV EF\>50% (TTE)

You may not qualify if:

  • preoperative cardiac dysrhythmia
  • preoperative IABP
  • use of other inotropic agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Medical Center

Seoul, 143-729, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial IschemiaHeart Valve DiseasesSprains and Strains

Interventions

Milrinone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

AmrinoneAminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Soi Lee

    Konkuk University Medical Center

    STUDY DIRECTOR

Central Study Contacts

Tae-Yop Kim, MD PhD

CONTACT

82-2-2030-5457taeyop@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 11, 2023

Study Start

November 3, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 19, 2024

Record last verified: 2024-01

Locations

KR(1)