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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Shock, Septic

Treatments: Biological: Routine biological analyses

Study type: Observational

Funder types: Other

Identifiers

NCT01231672

2008-A01214-51 (Other Identifier)

PHRC-I/2008/GL-03

Details and patient eligibility

About

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.

Full 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: [e-mail]

Enrollment: 780 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

780 participants in 1 patient group

Septic shock patients

Treatment:

Biological: Routine biological analyses