Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients

Not Applicable

Completed

• Conditions: Sepsis; Septic Shock; Cancer
• Interventions: Other: SELDI-TOF MS for plasmatic proteic profile

• Registration Number: NCT00930085
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

The mortality induced by infections in onco-hematological patients is abnormally high at the acute phase of septic shock. Consequently, it is important to detect the population with a high risk of short term mortality among patients with a septic shock. The aim of this study is the evaluation of predictive proteic profile on the short term mortality in the acute phase of septic shock in cancer patients.

Detailed Description

Method: Monocentric prospective study with diagnostic and prognostic expectations.

Primary objective:

Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock.

Secondary objective:

Research of clinical and biological prognostic factors.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-06-27
• Study First Posted: 2009-06-30
• Primary Completion: 2011-04
• Study Completion: 2011-05
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-13
• Last Update Posted: 2011-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patient from oncology or hematology with a septic shock
• Patient aged 18 years and older
• Inclusion within the 24 hours of the septic shock in the intensive care unit
• Signed consent according to the emergency reglementation

Exclusion Criteria

• Pregnancy, breast feeding
• Patient with decision of care limitation
• Patient with legal protection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SELDI-TOF MS	SELDI-TOF MS for plasmatic proteic profile	The proteic profiling is performed by SELDI-TOF mass spectroscopy.

Primary Outcome Measures

Name	Time	Method
Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock.	1 month

Secondary Outcome Measures

Name	Time	Method
Research of clinical and biological prognostic factors.	1 month

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, France