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

Shock, Septic Clinical Trial

— SEPSICOAG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231672
• Other study ID #: PHRC-I/2008/GL-03
• Secondary ID: 2008-A01214-51
• Status: Completed
• Phase: N/A
• First received: October 29, 2010
• Last updated: March 26, 2015
• Start date: April 2009
• Est. completion date: October 2013

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 780
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Shock
• Shock, Septic

Intervention

Biological:
• Routine biological analyses
Bilirubinemia (total and conjugated), hematology, hemogram, SOFA score

Locations

Country	Name	City	State
France	CHU de Clermont Ferrand - Hôpital Estaing	Clermont Ferrand
France	AP-HM Hôpital Nord	Marseille
France	APHM - Hôpital de la Conception	Marseille
France	Centre Hospitalier Universitaire de Montpellier	Montpellier
France	CHU de Nice	Nice
France	Centre Hospitalier Universitaire de Nîmes	Nîmes
France	CHU de Saint Etienne	Saint Etienne cedex 2

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of the studied prognostic score	The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death.; The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002).	24 hours (studied score parameters); 1 month (mortality)	No
Primary	Negative predictive value of the studied prognostic score	The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death.; The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002).	24 hours (studied score parameters); 1 month (mortality)	No
Secondary	AUC of the studied prognostic score	Biological parameters at the time of intensive care unit admission and making up the prognostic score for death at 1 week will be collected. The event "death within 1 week" will be analyzed. For patients discharged from the department before the end of the first week, the clinician will still be informed of possible death. For the prognostic score at 1 week, a single biological parameter is used: fibrinogen. Age and SAPSII are also included in the score.	24 hours (studied score parameters); 1 week (mortality)	No
Secondary	Negative predictive value of the studied prognostic score	Biological parameters at the time of intensive care unit admission and making up the prognostic score for death at 1 week will be collected. The event "death within 1 week" will be analyzed. For patients discharged from the department before the end of the first week, the clinician will still be informed of possible death. For the prognostic score at 1 week, a single biological parameter is used: fibrinogen. Age and SAPSII are also included in the score.	24 hours (studied score parameters); 1 week (mortality)	No
Secondary	AUC of the studied prognostic score	Our secondary objective is to validate a clinicobiological score, including hemostasis parameters (clotting factors and coagulation activation) and a clinical score (SOFA) for predicting the occurrence of DIC in the first 5 days after inclusion.; The DIC score will be calculated according to ISTH (International Society on Thrombosis and Haemostasis) recommandations (Taylor et al, 2001).	24 hours (studied score parameters); 5 days (DIC)	No
Secondary	Negative predictive value for the studied prognostic score	Our secondary objective is to validate a clinicobiological score, including hemostasis parameters (clotting factors and coagulation activation) and a clinical score (SOFA) for predicting the occurrence of DIC in the first 5 days after inclusion.; The DIC score will be calculated according to ISTH (International Society on Thrombosis and Haemostasis) recommandations (Taylor et al, 2001).	24 hours (studied score parameters); 5 days (DIC)	No