Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients With Septic Shock (SEPSICOAG)
This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01231672
First received: October 29, 2010
Last updated: March 26, 2013
Last verified: March 2013
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Purpose
The primary goal of this study is to validate a 3-marker score as a predictor of death at one month among septic shock patients.
| Condition | Intervention |
|---|---|
|
Shock, Septic |
Biological: Routine biological analyses |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nīmes:
Primary Outcome Measures:
- AUC of the 3-marker score [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 780 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Septic shock patients |
Biological: Routine biological analyses
Bilirubinemia (total and conjugated), hematology, hemogram, SOFA score
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Severe septic shock patients entering intensive care units in the participating centers.
Criteria
Inclusion Criteria:
- patient (or representative) recieved 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
- leucocytes > 12000 µL-1 ou < 4000 µL-1 ou > 10% immature forms
- 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)
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231672
Contacts
| Contact: Géraldine M Lavigne-Lissalde, MD | +33.4.66.68.78.26 | geraldine.lavigne@chu-nimes.fr |
| Contact: Carey M Suehs, PhD | +33.4.66.68.67.88 | carey.suehs@chu-nimes.fr |
Locations
| France | |
| AP-HM Hôpital Nord | Recruiting |
| Marseille, France, 13915 | |
| Sub-Investigator: Claude Martin, MD PhD | |
| Sub-Investigator: Marc Leone, MD | |
| Centre Hospitalier Universitaire de Montpellier | Recruiting |
| Montpellier, France | |
| Sub-Investigator: Samir Jaber, MD Phd | |
| Sub-Investigator: Xavier Capdevila, MD PhD | |
| CHU de Nice | Recruiting |
| Nice, France | |
| Sub-Investigator: Carole Ichaï, MD PhD | |
| Centre Hospitalier Universitaire de Nîmes | Recruiting |
| Nîmes, France, 30029 | |
| Principal Investigator: Géraldine Lavigne-Lissalde, MD | |
| Sub-Investigator: Jean Yves Lefrant, MD PhD | |
| CHU de Saint Etienne | Recruiting |
| Saint Etienne cedex 2, France, 42055 | |
| Sub-Investigator: Serge Molliex, MD PhD | |
| Sub-Investigator: Patrick Mismetti, MD PhD | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
| Principal Investigator: | Géraldine Lavigne-Lissalde, MD | Centre Hospitalier Universitaire de Nîmes |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
| ClinicalTrials.gov Identifier: | NCT01231672 History of Changes |
| Other Study ID Numbers: | PHRC-I/2008/GL-03, 2008-A01214-51 |
| Study First Received: | October 29, 2010 |
| Last Updated: | March 26, 2013 |
| Health Authority: | France: Committee for the Protection of Personnes France: The Commission nationale de l’informatique et des libertés |
Additional relevant MeSH terms:
|
Shock Shock, Septic Pathologic Processes Sepsis Infection Systemic Inflammatory Response Syndrome |
Inflammation Hemostatics Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013