Infrahepatic Inferior Vena Cava Clamping During Hepatectomy

NCT ID: NCT00732979

Last Updated: 2013-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Infrahepatic inferior vena cava clamping

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

No infrahepatic inferior vena cava clamping

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Nuh Rahbari

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Heidelberg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 21412143 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19825186 (View on PubMed)

Other Identifiers

NNR-01

Identifier Type: -

Identifier Source: org_study_id