Vasodilator-induced Hypovolemia in Living Liver Donors

CVP and SVV During Living Donor Hepatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033967
• Other study ID #: MLN_SVV_CVP
• Status: Completed
• Phase: N/A
• First received: January 8, 2014
• Last updated: April 22, 2016
• Start date: January 2014

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• adult (20-60 yr)

• elective living liver donors

Exclusion Criteria:

• not obtained informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• vasodilator induced hypovolemia

Locations

Country	Name	City	State
Korea, Republic of	Seoul national University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	during living donor hepatectomy	Yes
Secondary	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	during living donor hepatectomy	Yes
Secondary	use of inotropics		during living donor hepatectomy	Yes
Secondary	estimated blood loss		during living donor hepatectomy	Yes