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Hepatic Mitochondrial Function in Sepsis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Institut d'Anesthesiologie des Alpes Maritimes.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00889083
First Posted: April 28, 2009
Last Update Posted: July 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes
  Purpose

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.


Condition
Sepsis Peritonitis

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 ]

Secondary Outcome Measures:
  • Quantification of adenine nucleotides [ Time Frame: during surgery ]
  • Quantification of oxidative stress markers [ Time Frame: during surgery ]
  • Correlation between SOFA score and mitochondrial complex activities [ Time Frame: 28 days ]

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)
Groups/Cohorts
Control
Non septic patients needing hepatic surgery
Sepsis
Septic patients needing surgery for peritonitis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No liver biopsy performed
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889083


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

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

Publications:
Responsible Party: Jean-Christophe Orban, CHU de Nice
ClinicalTrials.gov Identifier: NCT00889083     History of Changes
Other Study ID Numbers: IAAM-2009-1
First Submitted: April 24, 2009
First Posted: April 28, 2009
Last Update Posted: July 4, 2011
Last Verified: June 2011

Keywords provided by Institut d'Anesthesiologie des Alpes Maritimes:
Sepsis
Peritonitis
Mitochondria
Liver

Additional relevant MeSH terms:
Sepsis
Toxemia
Peritonitis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases