Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients With Septic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

780 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-10-30

Brief Summary

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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.

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Detailed Description

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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: [email protected]

Conditions

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Shock, Septic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Septic shock patients

Routine biological analyses

Intervention Type BIOLOGICAL

Bilirubinemia (total and conjugated), hematology, hemogram, SOFA score

Interventions

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Routine biological analyses

Bilirubinemia (total and conjugated), hematology, hemogram, SOFA score

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No