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
Sponsor:
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes
ClinicalTrials.gov Identifier:
NCT00889083
First received: April 24, 2009
Last updated: June 30, 2011
Last verified: June 2011
  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 ] [ 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)
Groups/Cohorts
Control
Non septic patients needing hepatic surgery
Sepsis
Septic patients needing surgery for peritonitis

  Eligibility

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

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
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: 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
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:
Sepsis
Peritonitis
Mitochondria
Liver

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

ClinicalTrials.gov processed this record on October 23, 2014