Organ Protection With Sevoflurane Postconditioning

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT00518908
• Collaborator: (none)
• Enrollment: 125
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

Organ protection, volatile anesthetics, postconditioning, hepatic surgery

Condition or Disease	Intervention/Treatment	Phase
Hepatectomy	Drug: Sevoflurane	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Role of Volatile Anesthetics for Hepatic Protection in Ischemia-reperfusion: Postconditioning
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sevoflurane Sevoflurane for pharmacological postconditioning	Drug: Sevoflurane; 3.2 Vol % for postconditioning
Experimental: Propofol Anesthesia maintenance with propofol instead of Sevoflurane postconditioning	Drug: Sevoflurane; 3.2 Vol % for postconditioning

Outcome Measures

Primary Outcome Measures

1. Liver transaminase AST [Postoperative phase until discharge]

   Peak value

Secondary Outcome Measures

1. ALT peak value [Postoperative phase until discharge]

2. Course of transaminases [From the day before surgery, to 6 hours after surgery, up to postoperative day 7]

3. Postoperative complications [Postoperative phase until discharge]

4. Length of hospital stay [Postoperative phase until discharge]

5. Need for prolonged intensive care unit stay (>24 hours) [Postoperative phase until discharge]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Zurich	Zurich		Switzerland

Sponsors and Collaborators

• University of Zurich

Investigators

• Study Director: 01 Studienregister MasterAdmins, UniversitaetsSpital Zuerich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00518908
• Other Study ID Numbers: StV 34-2007
• First Posted: Aug 21, 2007
• Last Update Posted: Jul 19, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: Ischemia reperfusion injury; Organ protection
• Additional relevant MeSH terms: Sevoflurane

Study Results

No Results Posted as of Jul 19, 2011