Infrahepatic Inferior Vena Cava Clamping During Hepatectomy

NCT00732979 | Completed DMC

• 1 other identifier: NNR-01
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Elective; hepatic; resection; due to any; reason.

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss

  End of operation

Study Arms (2)

A

EXPERIMENTAL

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

B

ACTIVE COMPARATOR

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

Interventions

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.

A

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.

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

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

Heidelberg, 69120, Germany

Location

Related Publications (2)

• 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.

  PMID: 21412143 DERIVED

• 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.

  PMID: 19825186 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 12, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

DE (1)