Infrahepatic Inferior Vena Cava Clamping During Hepatectomy

Hemorrhage Clinical Trial

— IVC CLAMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732979
• Other study ID #: NNR-01
• Status: Completed
• Phase: N/A
• First received: August 7, 2008
• Last updated: May 16, 2013
• Start date: March 2008
• Est. completion date: December 2011

Study information

• Verified date: May 2013
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Department of General, Visceral and Transplantation Surgery, University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood loss		End of operation	Yes