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:
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
  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