Infrahepatic Inferior Vena Cava Clamping During Hepatectomy (IVC CLAMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nuh Rahbari, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00732979
First received: August 7, 2008
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Hemorrhage
Procedure: Infrahepatic inferior vena cava clamping
Procedure: No infrahepatic inferior vena cava clamping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IVC CLAMP: Infrahepatic Inferior Vena Cava Clamping During Hepatectomy - A Randomized Controlled Trial

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Intraoperative blood loss [ Time Frame: End of operation ] [ Designated as safety issue: Yes ]

Enrollment: 152
Study Start Date: March 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00732979

Locations
Germany
Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
  More Information

No publications provided by Heidelberg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nuh Rahbari, MD, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00732979     History of Changes
Other Study ID Numbers: NNR-01
Study First Received: August 7, 2008
Last Updated: May 16, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
Elective
hepatic
resection
due to any
reason.

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014