Vasodilator-induced Hypovolemia in Living Liver Donors

NCT ID: NCT02033967

Last Updated: 2016-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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Induced hypovolemia is known to improve surgical field during living donor hepatectomy. This procedure is conventionally guided by monitoring the central venous pressure (CVP). Stroke volume variation (SVV) is a novel method to substitute with CVP to monitor cardiac preload. The investigators try to evaluate the relationship between CVP and SVV during CVP-guided vasodilator induced hypovolemia (validation study). Then, feasibility of vasodilator induced hypovolemia using the SVV calculated from the validation study will be tested (feasibility study).

Detailed Description

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This is a 2-phases study.

first phase validation study : Evaluation of the relationship between CVP and SVV during CVP-guided vasodilator induced hypovolemia

second phase feasibility study

: Comparison of the surgical field grade between validation study group(CVP guided group) and feasibility study group(SVV guided group)

Conditions

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CVP and SVV During Living Donor Hepatectomy Surgical Field Grade (Condition of Surgical Field; Bleeding, Tension of the IVC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CVP

Central venous pressure-guided vasodilator-induced hypovolemia

Group Type ACTIVE_COMPARATOR

vasodilator induced hypovolemia

Intervention Type PROCEDURE

SVV

stroke volume variation-guided vasodilator-induced hypovolemia

Group Type EXPERIMENTAL

vasodilator induced hypovolemia

Intervention Type PROCEDURE

Interventions

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vasodilator induced hypovolemia

Intervention Type PROCEDURE

Other Intervention Names

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Milrinone induced hypovolemia

Eligibility Criteria

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Inclusion Criteria

* adult (20-60 yr)
* elective living liver donors

Exclusion Criteria

* not obtained informed consent
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chul-Woo Jung

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul national University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee J, Kim WH, Ryu HG, Lee HC, Chung EJ, Yang SM, Jung CW. Stroke Volume Variation-Guided Versus Central Venous Pressure-Guided Low Central Venous Pressure With Milrinone During Living Donor Hepatectomy: A Randomized Double-Blinded Clinical Trial. Anesth Analg. 2017 Aug;125(2):423-430. doi: 10.1213/ANE.0000000000002197.

Reference Type DERIVED
PMID: 28632543 (View on PubMed)

Other Identifiers

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MLN_SVV_CVP

Identifier Type: -

Identifier Source: org_study_id

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