NCT00732979

Infrahepatic Inferior Vena Cava Clamping During Hepatectomy

IVC CLAMP: Infrahepatic Inferior Vena Cava Clamping During Hepatectomy - A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Hemorrhage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-08-12
• Last updated: 2013-05-17

Locations

1 site across 1 country: Germany