Trials / Completed
CompletedNCT01231672
Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients With Septic Shock
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 780 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Nīmes · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Routine biological analyses | Bilirubinemia (total and conjugated), hematology, hemogram, SOFA score |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2013-10-30
- Completion
- 2013-10-30
- First posted
- 2010-11-01
- Last updated
- 2025-11-17
Locations
7 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01231672. Inclusion in this directory is not an endorsement.