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Vasodilator-induced Hypovolemia in Living Liver Donors

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

vasodilator induced hypovolemia

About this trial

This is an interventional treatment trial for CVP and SVV During Living Donor Hepatectomy focused on measuring liver donor, hepatectomy, vasodilator, central venous pressure, stroke volume variation

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

adult (20-60 yr)
elective living liver donors

Exclusion Criteria:

not obtained informed consent

Sites / Locations

Seoul national University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CVP

SVV

Arm Description

Central venous pressure-guided vasodilator-induced hypovolemia

stroke volume variation-guided vasodilator-induced hypovolemia

Outcomes

Primary Outcome Measures

target value of SVV

Target value of SVV is calculated from the linear regression equation that was calculated from scatter plot made with CVP and SVV values during CVP-guided vasodilator induced hypovolemia (validation study).

Secondary Outcome Measures

surgical field

<4 point scale> Grade l: Very lax IVC and hepatic veins, minimal bleeding at resection plane, very easy to operate Grade ll: Lax IVC and hepatic veins, a little bleeding at resection plane, easy to operate Grade lll: Tense IVC and hepatic veins, appreciable bleeding at resection plane, somewhat difficult to operate Grade lV: Very tense IVC and hepatic veins, profuse bleeding at resection plane, very difficult to operate

use of inotropics

estimated blood loss

Full Information

NCT ID

NCT02033967

First Posted

January 8, 2014

Last Updated

April 22, 2016

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02033967

Brief Title

Vasodilator-induced Hypovolemia in Living Liver Donors

Official Title

Vasodilator-induced Hypovolemia in Living Liver Donors: Central Venous Pressure-guided vs Stroke Volume Variation-guided Technique

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

liver donor, hepatectomy, vasodilator, central venous pressure, stroke volume variation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CVP

Arm Type

Active Comparator

Arm Description

Central venous pressure-guided vasodilator-induced hypovolemia

Arm Title

SVV

Arm Type

Experimental

Arm Description

stroke volume variation-guided vasodilator-induced hypovolemia

Intervention Type

Procedure

Intervention Name(s)

vasodilator induced hypovolemia

Other Intervention Name(s)

Milrinone induced hypovolemia

Primary Outcome Measure Information:

Title

target value of SVV

Description

Time Frame

during living donor hepatectomy

Secondary Outcome Measure Information:

Title

surgical field

Description

Time Frame

during living donor hepatectomy

Title

use of inotropics

Time Frame

during living donor hepatectomy

Title

estimated blood loss

Time Frame

during living donor hepatectomy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: adult (20-60 yr) elective living liver donors Exclusion Criteria: not obtained informed consent

Facility Information:

Facility Name

Seoul national University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

28632543

Citation

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.

Results Reference

derived

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Vasodilator-induced Hypovolemia in Living Liver Donors

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