NCT00966745

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
Last Updated

August 27, 2009

Status Verified

August 1, 2009

Enrollment Period

11 months

First QC Date

August 13, 2009

Last Update Submit

August 26, 2009

Conditions

Hepatectomy

Keywords

surgical field condition

Outcome Measures

Primary Outcomes (1)

  • condition of surgical field

    intraoperative period (from the start of surgery to end of living donor hepatectomy)

Secondary Outcomes (1)

  • 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)

Study Arms (2)

milrinone

ACTIVE COMPARATOR

milrinone infusion

Drug: milrinone

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

milrinoneDRUG
milrinone
placeboDRUG
placebo

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Living liver donors

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Milrinone

Intervention Hierarchy (Ancestors)

AmrinoneAminopyridinesAminesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 27, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 27, 2009

Record last verified: 2009-08

Locations

KR(1)