Clinical trial NCT01606631: Role of Beta-blockers in the Prevention on the Arisen of a Severe Sepsis (TESS)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community-Acquired Infections
Keywords: severe sepsis
toxic shock
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2012-05-28
Enrollment: 2444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Brief summary: 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. But an eventual protective role of beta-blockers (anti-hypertensive drug) in their occurrence on a community infection has never been studied. The objective of this study is to evaluate this role.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Common characteristics of cases and controls:
* Patients aged of more than 18 years old
* Hospitalized patients, during the period of study, via the ICU of the participating hospital center, for a community infectious pathology:

  * lower respiratory infections (pneumonia)
  * intra-abdominal infections (cholangitis, diverticulitis, peritonitis)
  * urinary parenchymal infection (pyelonephritis complicated or without abscess, prostatitis, orchitis, epididymitis)
  * infections of skin and soft tissue infections (cellulitis, fasciitis)
  * meningitis, endocarditis, osteo-articular infections, salpingitis

Definition of cases:

* Patient included in the study and admitted to the emergency service either directly from ICU or after a hospitalization in a specialty for severe sepsis or septic shock on their infectious disease community.

Definition of controls:

* Patient included in the study with an infectious disease community, admitted to a specialty, and have not progressed to severe sepsis or septic shock before being released from the hospital.

Non inclusion Criteria:

* Opposition of the patient to the IT processing of its data within the framework of this observational study.
* Exclusion criteria: Occurrence, during hospitalization, a severe sepsis or septic shock associated with a nosocomial superinfection.

Primary outcomes:
measure: The primary outcome is the occurrence of severe sepsis, moving toward or away from septic shock.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital (Pontchaillou)
state: Ille-et-Vilaine
city: Brest
country: France
facility: Brest University Hospital
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Garches
country: France
facility: Groupe hospitalier Raymond Poincaré, AP-HP
city: Grenoble
country: France
facility: Grenoble University Hospital (A. Michallon)
city: Limoges
country: France
facility: Limoges University Hospital (Hospital Dupuytren)
city: Nancy
country: France
facility: Nancy University Hospital (Jeanne d'Arc)
city: Saint Etienne
country: France
facility: Saint Etienne University Hospital (Bellevue)
city: Tours
country: France
facility: Tours University Hospital (Bretonneau)
Study officials:
affiliation: Rennes University Hospital - CIC
name: Bellissant Eric, MD, PhD
role: STUDY_DIRECTOR
References: