SepsisNCT00889083
Hepatic Mitochondrial Function in Sepsis
An observational study of Sepsis and Peritonitis, run by Professor C ICHAI at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Peritonitis
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Septic group : Peritonitis patients needing surgery
- Non septic group : Patients needing hepatic surgery
Who cannot join
- No liver biopsy performed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Hepatic Mitochondrial Function in Sepsis
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.
- Conditions
- Sepsis, Peritonitis
- Keywords
- Sepsis, Peritonitis, Mitochondria, Liver
- Medical subject headings
- Sepsis, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Non septic patients needing hepatic surgery | |
| Sepsis | Septic patients needing surgery for peritonitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial complex activities
Measured: during surgery
Secondary outcomes (3)
Quantification of adenine nucleotides
Measured: during surgery
Quantification of oxidative stress markers
Measured: during surgery
Correlation between SOFA score and mitochondrial complex activities
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startApr 2009 (estimated)
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: no patients to include
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor C ICHAI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor C ICHAI, Institut d'Anesthesiologie des Alpes Maritimes
- Investigators
- Carole Ichai, MD, PhD, Study chair, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889083
- Sponsor's protocol ID
- IAAM-2009-1
- Status last verified
- Jul 2020
- First submitted
- 24 Apr 2009
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/S0140-6736(02)09459-X.
PubMed 12133657Fredriksson 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.
PubMed 16803854
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hepatic Mitochondrial Function in Sepsis
- ClinicalTrials.gov ID
- NCT00889083
- Acronym / sponsor ID
- IAAM-2009-1
- Conditions
- Sepsis, Peritonitis
- Keywords
- Sepsis, Peritonitis, Mitochondria, Liver
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no patients to include
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Professor C ICHAIUniversity, hospital or other
- Study start
- Apr 2009 (estimated)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Non septic patients needing hepatic surgery |
| Sepsis | – | –Septic patients needing surgery for peritonitis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- Septic group : Peritonitis patients needing surgery
- Non septic group : Patients needing hepatic surgery
Key exclusion criteria (1 listed)
- No liver biopsy performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mitochondrial complex activities
Time frame: during surgery
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Background: PubMed 12133657Brealey 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.
- Background: PubMed 16803854Fredriksson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carole Ichai, MD, PhD study chair
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Peritonitis, run by Professor C ICHAI at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial complex activities (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00889083, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.