Infrahepatic Inferior Vena Cava Clamping During Hepatectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of General, Visceral and Transplantation Surgery, University of Heidelberg

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Aged 18 years
Scheduled for elective hepatic resection due to any reason
American Society of Anesthesiologists (ASA) score I to III
Written informed consent

Exclusion criteria

Medical conditions exposing patient at increased risk for not tolerating liver resection:
Cirrhosis (Child-Pugh B and C)
(Hereditary) coagulopathy
Medical conditions exposing patient at increased risk for not tolerating this trial's study interventions:
Severe heart disease (e.g. severe CAD requiring intervention, NYHA IV)
Pulmonary hypertension
Renal insufficiency (serum creatinin >2mg/dl or >177µmol/l; conversion factor 88.4 or requiring dialysis)
Severe hypernatremia (serum sodium >155mmol/l)
Severe hyperchloremia
For female subjects: pregnancy and lactation
Impaired mental state or language problems
Participation in other clinical trials or observation period of competing trials interfering with the endpoints of this trial
Former participation in the clinical trial
Expected lack of compliance

Treatment and study plan

Infrahepatic inferior vena cava clamping

Procedure

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.

No infrahepatic inferior vena cava clamping

Procedure

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.

Primary outcomes

Intraoperative blood loss

Time frame: End of operation

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Acronym: IVC CLAMP

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Aug 12, 2008
Registry last updated: May 17, 2013

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.

Published trials that share one or more normalized conditions with this study.

Completed