Milrinone During Living Donor Hepatectomy | NCT00966745

Studies
Milrinone During Living Donor Hepatectomy

NCT00966745

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Aug 27, 2009Estimated

Enrollment

38Actual

Phase

Not Applicable

Conditions

Hepatectomy

Interventions

milrinone
placebo

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

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Aug 13, 2009

First Submission Date that Met QC Criteria

Aug 26, 2009

First Posted Date

Aug 27, 2009Estimated

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

Aug 26, 2009

Last Update Posted Date

Aug 27, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Maintaining a low central venous pressure during living donor hepatectomy is routine practice. The investigators tried to test the hypothesis that using milrinone to maintain a low central venous pressure (CVP) during is associated with a superior surgical field and less blood loss.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
milrinone	Active Comparator	milrinone infusion	Drug: milrinone
placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
milrinone	Drug		milrinone
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
condition of surgical field		intraoperative period (from the start of surgery to end of living donor hepatectomy)

Secondary Outcomes

Measure	Description	Time Frame
the use of vasopressor and diuretics to maintain hemodynamic stability and low CVP status, respectively		intraoperative period (from the start of surgery to end of living donor hepatectomy)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Living liver donors

Exclusion Criteria:

Donors with concurrent cardiac, pulmonary, and urologic disease
Hepatectomy performed laparoscopically

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

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

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Browse Branches

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