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Infrahepatic Inferior Vena Cava Clamping During Hepatectomy (IVC CLAMP)

Primary Purpose

Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Infrahepatic inferior vena cava clamping
No infrahepatic inferior vena cava clamping
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage focused on measuring Elective, hepatic, resection, due to any, reason.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm 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.

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.

Outcomes

Primary Outcome Measures

Intraoperative blood loss

Secondary Outcome Measures

Full Information

First Posted
August 7, 2008
Last Updated
May 16, 2013
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT00732979
Brief Title
Infrahepatic Inferior Vena Cava Clamping During Hepatectomy
Acronym
IVC CLAMP
Official Title
IVC CLAMP: Infrahepatic Inferior Vena Cava Clamping During Hepatectomy - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
Elective, hepatic, resection, due to any, reason.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm 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.
Arm Title
B
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Infrahepatic inferior vena cava clamping
Intervention Description
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
Intervention Name(s)
No infrahepatic inferior vena cava clamping
Intervention 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.
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Time Frame
End of operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of General, Visceral and Transplantation Surgery, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21412143
Citation
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.
Results Reference
derived
PubMed Identifier
19825186
Citation
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.
Results Reference
derived

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Infrahepatic Inferior Vena Cava Clamping During Hepatectomy

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