Milrinone on Right Ventricular Strain in Cardiac Surgery | NCT06077721

Studies
Milrinone on Right Ventricular Strain in Cardiac Surgery

NCT06077721

Sponsor

Konkuk University Medical Center

Status

Unknown status

Last Update Posted

Jan 19, 2024Actual

Enrollment

41Estimated

Phase

Not provided

Conditions

Ischemic Heart Disease
Valvular Heart Disease

Interventions

Milrinone

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 3, 2023Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Oct 5, 2023

First Submission Date that Met QC Criteria

Oct 10, 2023

First Posted Date

Oct 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2024

Last Update Posted Date

Jan 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical CenterPrincipal Investigator

Lead Sponsor

Konkuk University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

41Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Milrinone	Drug	giving intravenous milrinone: 50 mcg/kg loading dose by IV push over 10 minutes, then 0.375-0.75 mcg/kg/ min infusion		Milrinone intravenous administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1. Right ventricular strain		15 min after milrinone administration

Secondary Outcomes

Measure	Description	Time Frame
Left ventricular strain		15 min after milrinone administration
Left ventricular ejection fraction		15 min after milrinone administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

preoperative cardiac dysrhythmia
preoperative IABP
use of other inotropic agents

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

valvular heart disease, coronary heart disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tae-Yop Kim, MD PhD	Contact	82-2-2030-5457		taeyop@gmail.com

Overall Officials

Name	Affiliation	Role
Soi Lee	Konkuk University Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Konkuk University Medical Center	Recruiting	Seoul		143-729	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017202	Myocardial Ischemia
D006349	Heart Valve Diseases
D013180	Sprains and Strains

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020105	Milrinone

Ancestor Terms

ID	Term
D000676	Amrinone
D000631	Aminopyridines
D000588	Amines
D009930	Organic Chemicals
D011725

Browse Leaves

Not provided

Browse Branches

Not provided