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NCT Number: NCT02033967

Vasodilator-induced Hypovolemia in Living Liver Donors

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).

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Key information

Conditions

CVP and SVV During Living Donor Hepatectomy Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Surgical Field Grade (Condition of Surgical Field; Bleeding, Tension of the IVC)

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul national University Hospital

Seoul, 110-744, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • not obtained informed consent

Treatment and study plan

vasodilator induced hypovolemia

Procedure

Other names: Milrinone induced hypovolemia

Primary outcomes

  1. 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 outcomes

  1. 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

  2. use of inotropics

    Time frame: during living donor hepatectomy

  3. estimated blood loss

    Time frame: during living donor hepatectomy

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
First posted
Jan 13, 2014
Registry last updated
Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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