Sepsis Clinical Trial
Official title:
Evaluation of Hepatic Mitochondrial Function in Sepsis
NCT number | NCT00889083 |
Other study ID # | IAAM-2009-1 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | April 2009 |
Est. completion date | April 2012 |
Verified date | July 2020 |
Source | Institut d'Anesthesiologie des Alpes Maritimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Septic group : Peritonitis patients needing surgery - Non septic group : Patients needing hepatic surgery Exclusion Criteria: - No liver biopsy performed |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nice | Nice |
Lead Sponsor | Collaborator |
---|---|
Professor C ICHAI |
France,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mitochondrial complex activities | during surgery | ||
Secondary | Quantification of adenine nucleotides | during surgery | ||
Secondary | Quantification of oxidative stress markers | during surgery | ||
Secondary | Correlation between SOFA score and mitochondrial complex activities | 28 days |
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