Isoflurane Preconditioning for Liver Resections

This study has been terminated.
(We no longer had an appropriate patient population.Study closed)
Sponsor:
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01031550
First received: December 10, 2009
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

The objective is to examine the efficacy of isoflurane (inhaled anesthetic gas) to induce clinically effective preconditioning in patients undergoing elective hepatic surgery.


Condition Intervention
Liver Disease
Drug: isoflurane
Other: standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Isoflurane Induced Anesthetic Preconditioning in Elective Liver Resection

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Post Operative Complications Grade IIIb or Greater According to Clavien's Classification [ Time Frame: first 7 post operative days ] [ Designated as safety issue: No ]
    Post operative complications grade IIIB or greater according to Clavien's classification


Secondary Outcome Measures:
  • Peak Postoperative AST, ALT and T Bili [ Time Frame: first 7 post operative days ] [ Designated as safety issue: No ]
  • Length of ICU and Hospital Stay [ Time Frame: first 7 post operative days ] [ Designated as safety issue: No ]
  • Decrease in Liver Lipid Peroxidation and Apoptosis [ Time Frame: first 7 post operative days ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard anesthetic management
standard anesthetic management
Other: standard of care
standard of care
Experimental: preconditioning with 2 MAC isoflurane group
preconditioning with isoflurane
Drug: isoflurane
isoflurane an anesthetic gas agent administered at specific times at a flow of 2 MAC

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with liver tumors undergoing liver resection of > 1 segment liver resection must be performed with inflow occlusion > 30 min

Exclusion Criteria:

  • patients undergoing liver resection of one segment or less
  • patients undergoing laparoscopic liver resection
  • patients in whom the liver resection is performed with no inflow occlusion or inflow occlusion of < 30 min
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031550

Locations
United States, New Jersey
UMDNJ-University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Yuriy Gubenko, MD Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Anesthesia, Investigator Intiated Dept of Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01031550     History of Changes
Other Study ID Numbers: 0120090226
Study First Received: December 10, 2009
Results First Received: September 16, 2013
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
liver resection for liver disease

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Anesthetics
Isoflurane
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014