Role of Beta-blockers in the Prevention on the Arisen of a Severe Sepsis (TESS)
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|ClinicalTrials.gov Identifier: NCT01606631|
Recruitment Status : Completed
First Posted : May 28, 2012
Last Update Posted : May 28, 2012
|Condition or disease|
The severe sepsis (SS) and toxic shock (TS) are both frequent and severe complications of infectious diseases. They are one of the top ten causes of death in industrialized countries. The adrenergic system is heavily involved in this pathological/physiological context. If the effect of various therapeutic strategies allowing the care of the SS/TS was widely estimated, the impact, positive or negative, therapeutic prescribed in the long term or more punctually - but be that as it may before the arisen of the sepsis - on the evolution of a community acute infectious pathology towards the SS/TS, had only little studied.
The main objective of this study is to estimate the possible protective role of a long-term prescription of a beta-blocker on the arisen of the SS/TS in patients having an acute infectious pathology of community origin.
The secondary objective will be to estimate, at the patients having developed a SS/TS, the impact of this long-term prescription of beta-blockers on the mortality in intensive care unit (ICU).
|Study Type :||Observational|
|Actual Enrollment :||2444 participants|
|Observational Model:||Case Control|
|Official Title:||Evaluation of the Protective Role of Beta-blockers Prescribed in a Chronic Way on the Arisen of a Severe Septic Syndrome or a Toxic Shock at Patients Having a Community Infection|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Arm 1 : experimental (case)
Patients included in the study and admitted to the ICU either directly from UAA or after a hospitalization in a specialty, for a severe sepsis or septic shock on their infectious disease community.
Arm 2 : control
Patients included in the study with an infectious disease community, admitted to a specialty, and have not progressed to severe sepsis or septic shock before hospital discharge.
- The primary outcome is the occurrence of severe sepsis, moving toward or away from septic shock. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]From the date of randomization until the date of first documented assessed severe sepsis (moving toward or away from septic shock) up to the end of hospitalisation.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606631
|Rennes University Hospital (Pontchaillou)|
|Rennes, Ille-et-Vilaine, France, 35000|
|Brest University Hospital|
|Brest, France, 29200|
|Clermont-Ferrand University Hospital|
|Clermont-Ferrand, France, 63003|
|Groupe hospitalier Raymond Poincaré, AP-HP|
|Garches, France, 92380|
|Grenoble University Hospital (A. Michallon)|
|Grenoble, France, 38048|
|Limoges University Hospital (Hospital Dupuytren)|
|Limoges, France, 87042|
|Nancy University Hospital (Jeanne d'Arc)|
|Nancy, France, 54201|
|Saint Etienne University Hospital (Bellevue)|
|Saint Etienne, France, 42055|
|Tours University Hospital (Bretonneau)|
|Tours, France, 37044|
|Study Director:||Bellissant Eric, MD, PhD||Rennes University Hospital - CIC|