Hepatic Mitochondrial Function in Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Institut d'Anesthesiologie des Alpes Maritimes.
Recruitment status was  Recruiting
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes
ClinicalTrials.gov Identifier:
First received: April 24, 2009
Last updated: June 30, 2011
Last verified: June 2011

Multi-organ failure due to sepsis is a major cause of death in critically ill patients. But the mechanisms leading to this condition are not fully understood. Mitochondrial dysfunction has been shown in skeletal muscle of critically ill septic patients. Liver is very important in sepsis as it is responsible of the synthesis of several inflammatory proteins. Moreover hepatic failure is associated to a bad outcome.

The aim of this study is to evaluate the hepatic mitochondrial function in sepsis.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Hepatic Mitochondrial Function in Sepsis

Resource links provided by NLM:

Further study details as provided by Institut d'Anesthesiologie des Alpes Maritimes:

Primary Outcome Measures:
  • Mitochondrial complex activities [ Time Frame: during surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantification of adenine nucleotides [ Time Frame: during surgery ] [ Designated as safety issue: No ]
  • Quantification of oxidative stress markers [ Time Frame: during surgery ] [ Designated as safety issue: No ]
  • Correlation between SOFA score and mitochondrial complex activities [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Liver biopsies

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Non septic patients needing hepatic surgery
Septic patients needing surgery for peritonitis


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample

Inclusion Criteria:

  • Septic group : Peritonitis patients needing surgery
  • Non septic group : Patients needing hepatic surgery

Exclusion Criteria:

  • No liver biopsy performed
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00889083

Contact: Jean-Christophe Orban, MD 0033611947008 orban.j@chu-nice.fr
Contact: Carole Ichai, MD, PhD carole.ichai@unice.fr

CHU de Nice Recruiting
Nice, France, 06003
Principal Investigator: Jean-Christophe Orban, MD         
Sponsors and Collaborators
Institut d'Anesthesiologie des Alpes Maritimes
Study Chair: Carole Ichai, MD, PhD CHU de Nice
  More Information

Responsible Party: Jean-Christophe Orban, CHU de Nice
ClinicalTrials.gov Identifier: NCT00889083     History of Changes
Other Study ID Numbers: IAAM-2009-1 
Study First Received: April 24, 2009
Last Updated: June 30, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut d'Anesthesiologie des Alpes Maritimes:

Additional relevant MeSH terms:
Digestive System Diseases
Intraabdominal Infections
Pathologic Processes
Peritoneal Diseases
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on May 26, 2016