Clinical trial NCT01231672: Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients With Septic Shock
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock, Septic
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe septic shock patients entering intensive care units in the participating centers.

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: AUC of the studied prognostic score
timeFrame: 24 hours (studied score parameters); 1 month (mortality)
measure: Negative predictive value of the studied prognostic score
timeFrame: 24 hours (studied score parameters); 1 month (mortality)
Secondary outcomes:
measure: AUC of the studied prognostic score
timeFrame: 24 hours (studied score parameters); 1 week (mortality)
measure: Negative predictive value of the studied prognostic score
timeFrame: 24 hours (studied score parameters); 1 week (mortality)
measure: AUC of the studied prognostic score
timeFrame: 24 hours (studied score parameters); 5 days (DIC)
measure: Negative predictive value for the studied prognostic score
timeFrame: 24 hours (studied score parameters); 5 days (DIC)
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand - Hôpital Estaing
city: Marseille
country: France
facility: APHM - Hôpital de la Conception
city: Marseille
country: France
facility: AP-HM Hôpital Nord
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Nice
country: France
facility: CHU de Nice
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
city: Saint Etienne cedex 2
country: France
facility: CHU de Saint Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Géraldine Lavigne-Lissalde, MD
role: PRINCIPAL_INVESTIGATOR
References: