Organ Protection With Sevoflurane Postconditioning

Hepatectomy Clinical Trial

Official title:

Role of Volatile Anesthetics for Hepatic Protection in Ischemia-reperfusion: Postconditioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518908
• Other study ID #: StV 34-2007
• Status: Completed
• Phase: N/A
• First received: August 20, 2007
• Last updated: July 18, 2011
• Start date: January 2008
• Est. completion date: September 2010

Study information

• Verified date: July 2011
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Organ protection, volatile anesthetics, postconditioning, hepatic surgery

Description:

This study aims at the evaluation of a potential attenuation of ischemic-reperfusion injury in the liver with sevoflurane postconditioning upon reperfusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion criteria:

• older than 18 years

• patients undergoing liver resection (benign or malignant tumors)

Exclusion criteria:

• non-german speakers

• laparoscopic liver resection

• coagulopathy (platelets < 50'000/ml, Quick < 50%)

• liver cirrhosis

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatectomy

Intervention

Drug:
• Sevoflurane
3.2 Vol % for postconditioning

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver transaminase AST	Peak value	Postoperative phase until discharge	No
Secondary	ALT peak value		Postoperative phase until discharge	No
Secondary	Course of transaminases		From the day before surgery, to 6 hours after surgery, up to postoperative day 7	No
Secondary	Postoperative complications		Postoperative phase until discharge	Yes
Secondary	Length of hospital stay		Postoperative phase until discharge	No
Secondary	Need for prolonged intensive care unit stay (>24 hours)		Postoperative phase until discharge	No