NCT00889083

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

April 24, 2009

Last Update Submit

July 29, 2020

Conditions

Keywords

SepsisPeritonitisMitochondriaLiver

Outcome Measures

Primary Outcomes (1)

  • Mitochondrial complex activities

    during surgery

Secondary Outcomes (3)

  • Quantification of adenine nucleotides

    during surgery

  • Quantification of oxidative stress markers

    during surgery

  • Correlation between SOFA score and mitochondrial complex activities

    28 days

Study Arms (2)

Control

Non septic patients needing hepatic surgery

Sepsis

Septic patients needing surgery for peritonitis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

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

You may not qualify if:

  • No liver biopsy performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

Related Publications (2)

  • 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. doi: 10.1016/S0140-6736(02)09459-X.

    PMID: 12133657BACKGROUND
  • Fredriksson K, Hammarqvist F, Strigard 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. doi: 10.1152/ajpendo.00218.2006. Epub 2006 Jun 27.

    PMID: 16803854BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsies

MeSH Terms

Conditions

SepsisPeritonitis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsIntraabdominal InfectionsPeritoneal DiseasesDigestive System Diseases

Study Officials

  • Carole Ichai, MD, PhD

    Centre Hospitalier Universitaire de Nice

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Chair of IAAM

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 28, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 31, 2020

Record last verified: 2020-07

Locations