Infrahepatic Inferior Vena Cava Clamping During Hepatectomy (IVC CLAMP)

Heidelberg University

Status: Completed

Conditions: Hemorrhage

Treatments: Procedure: No infrahepatic inferior vena cava clamping; Procedure: Infrahepatic inferior vena cava clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT00732979

NNR-01

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 2 patient groups

A

Experimental group

Description:

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.

Treatment:

Procedure: Infrahepatic inferior vena cava clamping

B

Active Comparator group

Description:

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.

Treatment:

Procedure: No infrahepatic inferior vena cava clamping