Vasodilator-induced Hypovolemia in Living Liver Donors

Overview

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).

Full Title of Study: “Vasodilator-induced Hypovolemia in Living Liver Donors: Central Venous Pressure-guided vs Stroke Volume Variation-guided Technique”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: January 2015

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)

Interventions

  • Procedure: vasodilator induced hypovolemia

Arms, Groups and Cohorts

  • Active Comparator: CVP
    • Central venous pressure-guided vasodilator-induced hypovolemia
  • Experimental: SVV
    • stroke volume variation-guided vasodilator-induced hypovolemia

Clinical Trial Outcome Measures

Primary Measures

  • target value of SVV
    • Time Frame: 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 Measures

  • surgical field
    • Time Frame: 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
    • Time Frame: during living donor hepatectomy
  • estimated blood loss
    • Time Frame: during living donor hepatectomy

Participating in This Clinical Trial

Inclusion Criteria

  • adult (20-60 yr) – elective living liver donors Exclusion Criteria:

  • not obtained informed consent

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chul-Woo Jung, associate professor – Seoul National University Hospital

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