Shock, SepticSEPSICOAGNCT01231672
Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients With Septic Shock
An observational study of Shock, Septic, run by Centre Hospitalier Universitaire de Nīmes at 7 sites in France.
Trial summary
A prognostic score was proposed by the investigative team to predict death at 1 month. This score is based on certain biological markers, scored under emergency conditions in the first 24 hours of routine clinical practice management for septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Septic
- What is being tested?
- Routine biological analyses
- How many people
- 780 participants
- Where
- 7 sitesFrance
- Study dates
- Apr 2009to 30 Oct 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Severe septic shock patients entering intensive care units in the participating centers.
Who may be able to join
- patient (or representative) received the information notice
- patient has hemodynamic insufficiency of non-traumatic or cardiogenic origin associated with severe sepsis (treated with Noradrenalin) and organ dysfunction, hypoperfusion or hypotension
- body temperature > 38.3°C or < 36°C
- heart rate > 90 bpm
- Tachypnea > 20 C/min or PaCO2 < 32 mmHg or mechanical ventilation
- leukocytes > 12000 µL-1 ou < 4000 µL-1 ou > 10% immature forms
Show all 13Show fewer
- oliguria < 0.5 ml/kg/h for at least 2 hours
- abrupt alteration (24 h) of conscienceness
- thrombocytopenia < 100 000 G/L or disseminated intravascular coagulation
- mottled skin and / or capillary refill time> 3 sec
- PaO2/FiO2 < 300 mmHg ou < 40KPas
- Lactatemia > 2mMol/l
- septic shock: Systolic Blood Pressure (SBP) > 90 mmHg or need for vasopressors to maintain SBP> 90 mmHg despite a prior filling (20-30 ml / kg of macromolecules or 40 to 60 ml / kg of normal saline (or decrease in SBP> 40% in the hypertensive)
Who cannot join
- patient is dying or limitation or cessation of active treatment
- patient is already included in another trial
- patient or family refusal
- patient not affiliated with a social security system
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU de Clermont Ferrand - Hôpital Estaing
Clermont-Ferrand, 63003
APHM - Hôpital de la Conception
Marseille, 13385
AP-HM Hôpital Nord
Marseille, 13915
Centre Hospitalier Universitaire de Montpellier
Montpellier
CHU de Nice
Nice
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029
CHU de Saint Etienne
Saint-Etienne, 42055
About this study
Official title: Evaluation and Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients Entering Intensive Care Units for Septic Shock
A prognostic score was proposed by the investigative team to predict death at 1 month. This score is based on certain biological markers, scored under emergency conditions in the first 24 hours of routine clinical practice management for septic shock.
The main objective of this multicenter study is to validate the performance of the score in terms of area under the ROC curve and negative predictive value.
Read the detailed description
There are two secondary objectives:
- Validate a prognostic score for death at the end of the first week from initial data.
- Validate a predictive score of disseminated intravascular coagulation (DIC) in patients with septic shock by comparing with the Gold Standard of the International Society on Thrombosis and Haemostasis (overt-DIC in the first 5 days after inclusion).
As for the main objective, these scores are based on biological markers scored under emergency situations within the first 24 hours of routine clinical practice management for septic shock.
The objectives and endpoints stated correspond to the protocol directly submitted to ethics authorities prior to the first inclusion and can be verified by contacting the Committee for the Protection of Persons Sud Mediterranée III (mail: CPP SUD-MEDITERRANEE III, UFR MEDECINE 186, chemin du Carreau de Lanes CS 83021, 30908 NIMES Cedex 2 FRANCE. Study reference: 2008.11.04 bis) For more information: carey.suehs@chu-nimes.fr
- Conditions
- Shock, Septic
- Being tested
- Routine biological analyses
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine biological analysesBiological
Bilirubinemia (total and conjugated), hematology, hemogram, SOFA score
| Study group | Role | What they receive |
|---|---|---|
| Septic shock patients | Not described Receives: Biological: Routine biological analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of the studied prognostic score
The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death.
The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002).
Measured: 24 hours (studied score parameters); 1 month (mortality)
Negative predictive value of the studied prognostic score
The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death.
The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002).
Measured: 24 hours (studied score parameters); 1 month (mortality)
Secondary outcomes (4)
AUC of the studied prognostic score
Biological parameters at the time of intensive care unit admission and making up the prognostic score for death at 1 week will be collected. The event "death within 1 week" will be analyzed. For patients discharged from the department before the end of the first week, the clinician will still be informed of possible death. For the prognostic score at 1 week, a single biological parameter is used: fibrinogen. Age and SAPSII are also included in the score.
Measured: 24 hours (studied score parameters); 1 week (mortality)
Negative predictive value of the studied prognostic score
Biological parameters at the time of intensive care unit admission and making up the prognostic score for death at 1 week will be collected. The event "death within 1 week" will be analyzed. For patients discharged from the department before the end of the first week, the clinician will still be informed of possible death. For the prognostic score at 1 week, a single biological parameter is used: fibrinogen. Age and SAPSII are also included in the score.
Measured: 24 hours (studied score parameters); 1 week (mortality)
AUC of the studied prognostic score
Our secondary objective is to validate a clinicobiological score, including hemostasis parameters (clotting factors and coagulation activation) and a clinical score (SOFA) for predicting the occurrence of DIC in the first 5 days after inclusion.
The DIC score will be calculated according to ISTH (International Society on Thrombosis and Haemostasis) recommandations (Taylor et al, 2001).
Measured: 24 hours (studied score parameters); 5 days (DIC)
Negative predictive value for the studied prognostic score
Our secondary objective is to validate a clinicobiological score, including hemostasis parameters (clotting factors and coagulation activation) and a clinical score (SOFA) for predicting the occurrence of DIC in the first 5 days after inclusion.
The DIC score will be calculated according to ISTH (International Society on Thrombosis and Haemostasis) recommandations (Taylor et al, 2001).
Measured: 24 hours (studied score parameters); 5 days (DIC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startApr 2009
- Primary completion30 Oct 2013
- Study completion30 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shock, SepticStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Géraldine Lavigne-Lissalde, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231672
- Sponsor's protocol ID
- PHRC-I/2008/GL-03
- Other IDs
- 2008-A01214-51
- Acronym
- SEPSICOAG
- Status last verified
- Mar 2015
- First submitted
- 29 Oct 2010
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Gris JC, Faillie JL, Cochery-Nouvellon E, Lissalde-Lavigne G, Lefrant JY. ISTH overt disseminated intravascular coagulation score in patients with septic shock: automated immunoturbidimetric soluble fibrin assay vs. D-dimer assay. J Thromb Haemost. 2011 Jun;9(6):1252-5. doi: 10.1111/j.1538-7836.2011.04270.x. No abstract available.
PubMed 21645228
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients Entering Intensive Care Units for Septic Shock
- ClinicalTrials.gov ID
- NCT01231672
- Acronym / sponsor ID
- SEPSICOAG / PHRC-I/2008/GL-03
- Conditions
- Shock, Septic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- 30 Oct 2013 (actual)
- Study completion
- 30 Oct 2013 (actual)
- First posted
- 1 Nov 2010 (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.
A prognostic score was proposed by the investigative team to predict death at 1 month. This score is based on certain biological markers, scored under emergency conditions in the first 24 hours of routine clinical practice management for septic shock.
The main objective of this multicenter study is to validate the performance of the score in terms of area under the ROC curve and negative predictive value.
Detailed description
There are two secondary objectives:
- Validate a prognostic score for death at the end of the first week from initial data.
- Validate a predictive score of disseminated intravascular coagulation (DIC) in patients with septic shock by comparing with the Gold Standard of the International Society on Thrombosis and Haemostasis (overt-DIC in the first 5 days after inclusion).
As for the main objective, these scores are based on biological markers scored under emergency situations within the first 24 hours of routine clinical practice management for septic shock.
The objectives and endpoints stated correspond to the protocol directly submitted to ethics authorities prior to the first inclusion and can be verified by contacting the Committee for the Protection of Persons Sud Mediterranée III (mail: CPP SUD-MEDITERRANEE III, UFR MEDECINE 186, chemin du Carreau de Lanes CS 83021, 30908 NIMES Cedex 2 FRANCE. Study reference: 2008.11.04 bis) For more information: carey.suehs@chu-nimes.fr
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic shock patients | – | Biological: Routine biological analyses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe septic shock patients entering intensive care units in the participating centers.
Key inclusion criteria (13 listed)
- patient (or representative) received the information notice
- patient has hemodynamic insufficiency of non-traumatic or cardiogenic origin associated with severe sepsis (treated with Noradrenalin) and organ dysfunction, hypoperfusion or hypotension
- body temperature > 38.3°C or < 36°C
- heart rate > 90 bpm
- Tachypnea > 20 C/min or PaCO2 < 32 mmHg or mechanical ventilation
Key exclusion criteria (4 listed)
- patient is dying or limitation or cessation of active treatment
- patient is already included in another trial
- patient or family refusal
- patient not affiliated with a social security system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine biological analysesBilirubinemia (total and conjugated), hematology, hemogram, SOFA score | Biological | Septic shock patients |
Primary outcome
AUC of the studied prognostic score
Time frame: 24 hours (studied score parameters); 1 month (mortality)
The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death. The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002).
Negative predictive value of the studied prognostic score
Time frame: 24 hours (studied score parameters); 1 month (mortality)
The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death. The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002).
4 secondary outcomes
AUC of the studied prognostic score
Time frame: 24 hours (studied score parameters); 1 week (mortality)
Negative predictive value of the studied prognostic score
Time frame: 24 hours (studied score parameters); 1 week (mortality)
AUC of the studied prognostic score
Time frame: 24 hours (studied score parameters); 5 days (DIC)
Negative predictive value for the studied prognostic score
Time frame: 24 hours (studied score parameters); 5 days (DIC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 21645228Gris JC, Faillie JL, Cochery-Nouvellon E, Lissalde-Lavigne G, Lefrant JY. ISTH overt disseminated intravascular coagulation score in patients with septic shock: automated immunoturbidimetric soluble fibrin assay vs. D-dimer assay. J Thromb Haemost. 2011 Jun;9(6):1252-5. doi: 10.1111/j.1538-7836.2011.04270.x. No abstract available.
Related trials for Shock, Septic
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis
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.
Géraldine Lavigne-Lissalde, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, Septic, run by Centre Hospitalier Universitaire de Nīmes at 7 sites 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 13 inclusion and 4 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: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUC of the studied prognostic score (time frame: 24 hours (studied score parameters); 1 month (mortality)). The study lists 2 primary outcomes in all. 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 NCT01231672, which also lists 1 linked publication.
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 17 Nov 2025.