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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01606631
First received: February 24, 2012
Last updated: May 23, 2012
Last verified: April 2012
  Purpose

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.


Condition
Community-Acquired Infections

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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

Non applicable.


Enrollment: 2444
Study Start Date: September 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606631

Locations
France
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
Sponsors and Collaborators
Rennes University Hospital
Investigators
Study Director: Bellissant Eric, MD, PhD Rennes University Hospital - CIC
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01606631     History of Changes
Other Study ID Numbers: CNIL AR091723
Study First Received: February 24, 2012
Last Updated: May 23, 2012
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by Rennes University Hospital:
severe sepsis
toxic shock

Additional relevant MeSH terms:
Infection
Communicable Diseases
Community-Acquired Infections
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014