Role of Beta-blockers in the Prevention on the Arisen of a Severe Sepsis (TESS)

Community-Acquired Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606631
• Other study ID #: CNIL AR091723
• Status: Completed
• Phase: N/A
• First received: February 24, 2012
• Last updated: May 23, 2012
• Start date: September 2009
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2444
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Community-Acquired Infections

Locations

Country	Name	City	State
France	Brest University Hospital	Brest
France	Clermont-Ferrand University Hospital	Clermont-Ferrand
France	Groupe hospitalier Raymond Poincaré, AP-HP	Garches
France	Grenoble University Hospital (A. Michallon)	Grenoble
France	Limoges University Hospital (Hospital Dupuytren)	Limoges
France	Nancy University Hospital (Jeanne d'Arc)	Nancy
France	Rennes University Hospital (Pontchaillou)	Rennes	Ille-et-Vilaine
France	Saint Etienne University Hospital (Bellevue)	Saint Etienne
France	Tours University Hospital (Bretonneau)	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the occurrence of severe sepsis, moving toward or away from septic shock.	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.	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes