Severe SepsisNCT00361725
Comparative Study of the Protein C Pathway in Septic and Non Septic Patients With Organ Failure
An observational study of Severe Sepsis and Organ Failure, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
This is a comparative study performed in 3 groups of patients/subjects: 30 severe sepsis patients, 30 non-septic patients with organ failure, 30 healthy subjects. The only intervention is a venous blood sampling at the onset of the disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Sepsis, Organ Failure
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Oct 2003
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- severe sepsis patients or:
- non-septic acute organ failure patients or:
- healthy subjects matched for age and sex with severe sepsis patients
Who cannot join
- criteria for organ failure lasting for more than 24 hours
About this study
Official title: Comparative Study of the Protein C Pathway in Septic and Non Septic Patients
This is a comparative study performed in 3 groups of patients/subjects: 30 severe sepsis patients, 30 non-septic patients with organ failure, 30 healthy subjects.
The only intervention is a venous blood sampling at the onset of the disease.
The purpose of the study is to compare the PC pathway and expression and inflammatory genes between the 3 groups. The main hypothesis is that systemic inflammatory response and exacerbated coagulation activation are non specific of an infection as a triggering event.
Read the detailed description
analysis of the PC pathway
- PC activity
- PS activity
- soluble thrombomodulin
- soluble EPCR
- activated protein C
- quantitative flow cytometry on monocytes (thrombomodulin and EPCR)
- whole blood mRNA (Tissue factor, thrombomodulin and EPCR)
- inflammatory gene expression analysis by MLPA
- Conditions
- Severe Sepsis, Organ Failure
- Keywords
- severe sepsis, organ failure, activated protein C, thrombomodulin, EPCR
- Medical subject headings
- Sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startMar 2003
- Study completionOct 2003
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 Severe SepsisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Luc DIEHL, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361725
- Sponsor's protocol ID
- PROCAS
- Status last verified
- Jun 2006
- First submitted
- 7 Aug 2006
- Last updated
- 15 Aug 2006
- Results posted
- No
Publications
Borgel D, Clauser S, Bornstain C, Bieche I, Bissery A, Remones V, Fagon JY, Aiach M, Diehl JL. Elevated growth-arrest-specific protein 6 plasma levels in patients with severe sepsis. Crit Care Med. 2006 Jan;34(1):219-22. doi: 10.1097/01.ccm.0000195014.56254.8a.
PubMed 16374177Borgel D, Bornstain C, Reitsma PH, Lerolle N, Gandrille S, Dali-Ali F, Esmon CT, Fagon JY, Aiach M, Diehl JL. A comparative study of the protein C pathway in septic and nonseptic patients with organ failure. Am J Respir Crit Care Med. 2007 Nov 1;176(9):878-85. doi: 10.1164/rccm.200611-1692OC. Epub 2007 Aug 2.
PubMed 17673691
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Protein C Pathway in Septic and Non Septic Patients
- ClinicalTrials.gov ID
- NCT00361725
- Acronym / sponsor ID
- PROCAS
- Conditions
- Severe Sepsis, Organ Failure
- Keywords
- severe sepsis, organ failure, activated protein C, thrombomodulin, EPCR
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 90 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Mar 2003
- Study completion
- Oct 2003
- First posted
- 8 Aug 2006 (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.
This is a comparative study performed in 3 groups of patients/subjects: 30 severe sepsis patients, 30 non-septic patients with organ failure, 30 healthy subjects.
The only intervention is a venous blood sampling at the onset of the disease.
The purpose of the study is to compare the PC pathway and expression and inflammatory genes between the 3 groups. The main hypothesis is that systemic inflammatory response and exacerbated coagulation activation are non specific of an infection as a triggering event.
Detailed description
analysis of the PC pathway
- PC activity
- PS activity
- soluble thrombomodulin
- soluble EPCR
- activated protein C
- quantitative flow cytometry on monocytes (thrombomodulin and EPCR)
- whole blood mRNA (Tissue factor, thrombomodulin and EPCR)
- inflammatory gene expression analysis by MLPA
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- severe sepsis patients or:
- non-septic acute organ failure patients or:
- healthy subjects matched for age and sex with severe sepsis patients
Key exclusion criteria (1 listed)
- criteria for organ failure lasting for more than 24 hours
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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2006.
- Results publication: PubMed 16374177Borgel D, Clauser S, Bornstain C, Bieche I, Bissery A, Remones V, Fagon JY, Aiach M, Diehl JL. Elevated growth-arrest-specific protein 6 plasma levels in patients with severe sepsis. Crit Care Med. 2006 Jan;34(1):219-22. doi: 10.1097/01.ccm.0000195014.56254.8a.
- Derived from this study: PubMed 17673691Borgel D, Bornstain C, Reitsma PH, Lerolle N, Gandrille S, Dali-Ali F, Esmon CT, Fagon JY, Aiach M, Diehl JL. A comparative study of the protein C pathway in septic and nonseptic patients with organ failure. Am J Respir Crit Care Med. 2007 Nov 1;176(9):878-85. doi: 10.1164/rccm.200611-1692OC. Epub 2007 Aug 2.
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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.
Jean-Luc DIEHL, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Organ Failure, run by Assistance Publique - Hôpitaux de Paris.
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 3 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: stopped early, as of the sponsor's last update on 15 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
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 stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00361725, 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 15 Aug 2006.