Vasodilator-induced Hypovolemia in Living Liver Donors

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Chul-Woo Jung, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02033967
First received: January 8, 2014
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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).


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vasodilator-induced Hypovolemia in Living Liver Donors: Central Venous Pressure-guided vs Stroke Volume Variation-guided Technique

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • target value of SVV [ Time Frame: during living donor hepatectomy ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: during living donor hepatectomy ] [ Designated as safety issue: Yes ]
    <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 ] [ Designated as safety issue: Yes ]
  • estimated blood loss [ Time Frame: during living donor hepatectomy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: January 2014
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CVP
CVP-guided vasodilator-induced hypovolemia
Procedure: vasodilator induced hypovolemia
Other Name: Milrinone induced hypovolemia
Experimental: SVV
SVV-guided vasodilator-induced hypovolemia
Procedure: vasodilator induced hypovolemia
Other Name: Milrinone induced hypovolemia

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)

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • not obtained informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033967

Contacts
Contact: Chul-Woo Jung, MD spss@dreamwiz.com

Locations
Korea, Republic of
Seoul national University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jeonghee Cha       Jeonghee.cha@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Chul-Woo Jung, associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02033967     History of Changes
Other Study ID Numbers: MLN_SVV_CVP
Study First Received: January 8, 2014
Last Updated: January 13, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
liver donor
hepatectomy
vasodilator
central venous pressure
stroke volume variation

Additional relevant MeSH terms:
Hemorrhage
Hypovolemia
Pathologic Processes
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014