Vasodilator-induced Hypovolemia in Living Liver Donors

Not Applicable

Completed

• Conditions: Surgical Field Grade (Condition of Surgical Field; Bleeding, Tension of the IVC); CVP and SVV During Living Donor Hepatectomy
• Interventions: Procedure: vasodilator induced hypovolemia

• Registration Number: NCT02033967
• Lead Sponsor: Seoul National University Hospital

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)

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Primary Completion: 2015-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-22
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

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

Read More

Exclusion Criteria

• not obtained informed consent

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SVV	vasodilator induced hypovolemia	stroke volume variation-guided vasodilator-induced hypovolemia
CVP	vasodilator induced hypovolemia	Central venous pressure-guided vasodilator-induced hypovolemia

Primary Outcome Measures

Name	Time	Method
target value of SVV	during living donor hepatectomy	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

Name	Time	Method
surgical field	during living donor hepatectomy	\<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	during living donor hepatectomy
estimated blood loss	during living donor hepatectomy

Trial Locations

Locations (1)

Seoul national University Hospital; 🇰🇷 Seoul, Korea, Republic of