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Completed

NCT Number: NCT00930085

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

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.

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Key information

Conditions

Sepsis Cancer Infections Inflammation Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Paoli-Calmettes

Marseille, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SELDI-TOF MS for plasmatic proteic profile

Other

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).

Primary outcomes

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

    Time frame: 1 month

Secondary outcomes

  1. Research of clinical and biological prognostic factors.

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Acronym: PROTEOHSEPS

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2009
Registry last updated
Sep 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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