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

Rennes University Hospital

Status: Completed

Conditions: Community-Acquired Infections

Study type: Observational

Funder types: Other

Identifiers

NCT01606631

CNIL AR091723

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2,444 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

2,444 participants in 2 patient groups

Arm 1 : experimental (case)

Description:

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

Description:

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.