Hepatic Mitochondrial Function in Sepsis

• Sponsor: Professor C ICHAI (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00889083
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Sepsis; Peritonitis

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Evaluation of Hepatic Mitochondrial Function in Sepsis
• Anticipated Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Control Non septic patients needing hepatic surgery
Sepsis Septic patients needing surgery for peritonitis

Outcome Measures

Primary Outcome Measures

1. Mitochondrial complex activities [during surgery]

Secondary Outcome Measures

1. Quantification of adenine nucleotides [during surgery]

2. Quantification of oxidative stress markers [during surgery]

3. Correlation between SOFA score and mitochondrial complex activities [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Septic group : Peritonitis patients needing surgery

• Non septic group : Patients needing hepatic surgery

Exclusion Criteria:

• No liver biopsy performed

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nice	Nice		France	06003

Sponsors and Collaborators

• Professor C ICHAI

Investigators

• Study Chair: Carole Ichai, MD, PhD, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

• Brealey D, Brand M, Hargreaves I, Heales S, Land J, Smolenski R, Davies NA, Cooper CE, Singer M. Association between mitochondrial dysfunction and severity and outcome of septic shock. Lancet. 2002 Jul 20;360(9328):219-23.
• Fredriksson K, Hammarqvist F, Strigård K, Hultenby K, Ljungqvist O, Wernerman J, Rooyackers O. Derangements in mitochondrial metabolism in intercostal and leg muscle of critically ill patients with sepsis-induced multiple organ failure. Am J Physiol Endocrinol Metab. 2006 Nov;291(5):E1044-50. Epub 2006 Jun 27. Erratum in: Am J Physiol Endocrinol Metab. 2007 Apr;292(4):E1240.

• Responsible Party: Professor C ICHAI, Professor Chair of IAAM, Institut d'Anesthesiologie des Alpes Maritimes
• ClinicalTrials.gov Identifier: NCT00889083
• Other Study ID Numbers: IAAM-2009-1
• First Posted: Apr 28, 2009
• Last Update Posted: Jul 31, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Professor C ICHAI, Professor Chair of IAAM, Institut d'Anesthesiologie des Alpes Maritimes: Sepsis; Peritonitis; Mitochondria; Liver
• Additional relevant MeSH terms: Sepsis; Toxemia; Peritonitis

Study Results

No Results Posted as of Jul 31, 2020