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Infrahepatic Inferior Vena Cava Clamping During Hepatectomy

NCT00732979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2013-05-17

No results posted yet for this study

Summary

Intraoperative blood loss is a major concern during hepatic resection, as it has been shown to adversely affect patients' perioperative outcome. Reduction of central venous pressure during parenchymal transection has been shown to effectively lower liver hemorrhage. While CVP reduction is mainly achieved via fluid restriction and diuretics, dehydration may impair organ function. Moreover, it may lead to hemodynamic instability, particularly in case of severe bleeding. For this reason the technique of infrahepatic inferior vena cava clamping has been suggested which is able to lower CVP without the need for fluid restriction.

In the present study the two strategies to reduce CVP and by this intraoperative bleeding, namely fluid restriction and inferior vena cava clamping are compared with intraoperative blood loss as primary endpoint.

Conditions

Interventions

PROCEDURE

Infrahepatic inferior vena cava clamping

The inferior vena cava is circumferentially dissected below the liver and clamped with a vascular clamp. Patients in this study group will receive intravenous volume for maintenance of fluid hemostasis according to local standards.

PROCEDURE

No infrahepatic inferior vena cava clamping

Patients in this study group undergo hepatic resection following current standards of the Departments of Surgery and Anesthesiology, University of Heidelberg. Current practice consists of no type of vascular control in combination with CVP reduction below \< 5mmHg. CVP reduction is mainly attained using restricted intravenous fluid administration.

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00732979 on ClinicalTrials.gov