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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT00930085
First received: June 22, 2009
Last updated: September 13, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Sepsis
Septic Shock
Cancer
 Other: SELDI-TOF MS for plasmatic proteic profile

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Sepsis Shock
U.S. FDA Resources

Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Research of clinical and biological prognostic factors. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2008
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SELDI-TOF MS
The proteic profiling is performed by SELDI-TOF mass spectroscopy.
 Other: SELDI-TOF MS for plasmatic proteic profile
An extra blood sample is required to determine the plasmatic proteic profile used to identify one or several signatures which are correlated to the clinical evolution (mortality at D30).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930085

Locations
France
Institut Paoli-Calmettes
Marseille, France
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Djamel MOKART, MD Institut Paoli-Calmettes
  More Information

Additional Information:
official web site of the sponsor  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00930085     History of Changes
Other Study ID Numbers: PROTEOHSEPS/IPC 2005-011
Study First Received: June 22, 2009
Last Updated: September 13, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Paoli-Calmettes:
sepsis
septic shock

Additional relevant MeSH terms:
Sepsis
Shock
Shock, Septic
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013