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

Completed

• Conditions: Community-Acquired Infections

• Registration Number: NCT01606631
• Lead Sponsor: Rennes University Hospital

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).

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-02-24
• Status Verified: 2012-04
• Study First Submitted QC: 2012-05-23
• Last Update Submitted: 2012-05-23
• Study First Posted: 2012-05-28
• Last Update Posted: 2012-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2444

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the occurrence of severe sepsis, moving toward or away from septic shock.	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.

Trial Locations

Locations (9)

Rennes University Hospital (Pontchaillou); 🇫🇷 Rennes, Ille-et-Vilaine, France

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, France

Groupe hospitalier Raymond Poincaré, AP-HP; 🇫🇷 Garches, France

Saint Etienne University Hospital (Bellevue); 🇫🇷 Saint Etienne, France

Brest University Hospital; 🇫🇷 Brest, France

Nancy University Hospital (Jeanne d'Arc); 🇫🇷 Nancy, France

Grenoble University Hospital (A. Michallon); 🇫🇷 Grenoble, France

Limoges University Hospital (Hospital Dupuytren); 🇫🇷 Limoges, France

Tours University Hospital (Bretonneau); 🇫🇷 Tours, France