Infrahepatic Inferior Vena Cava Clamping During Hepatectomy (IVC CLAMP)

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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Procedure: Infrahepatic inferior vena cava clamping; Procedure: No infrahepatic inferior vena cava clamping

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Department of General, Visceral and Transplantation Surgery, University of Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; 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: 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.
Active Comparator: B; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraoperative blood loss	End of operation

Collaborators and Investigators

• Sponsor: Heidelberg University

Publications and helpful links

General Publications

• Rahbari NN, Koch M, Zimmermann JB, Elbers H, Bruckner T, Contin P, Reissfelder C, Schmidt T, Weigand MA, Martin E, Buchler MW, Weitz J. Infrahepatic inferior vena cava clamping for reduction of central venous pressure and blood loss during hepatic resection: a randomized controlled trial. Ann Surg. 2011 Jun;253(6):1102-10. doi: 10.1097/SLA.0b013e318214bee5.
• Rahbari NN, Zimmermann JB, Koch M, Bruckner T, Schmidt T, Elbers H, Reissfelder C, Weigand MA, Buchler MW, Weitz J. IVC CLAMP: infrahepatic inferior vena cava clamping during hepatectomy--a randomised controlled trial in an interdisciplinary setting. Trials. 2009 Oct 13;10:94. doi: 10.1186/1745-6215-10-94.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 7, 2008
• First Submitted That Met QC Criteria: August 11, 2008
• First Posted (Estimate): August 12, 2008

Study Record Updates

• Last Update Posted (Estimate): May 17, 2013
• Last Update Submitted That Met QC Criteria: May 16, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: resection; Elective; hepatic; due to any; reason.
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: NNR-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No