NCT01606631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,444

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
Last Updated

May 28, 2012

Status Verified

April 1, 2012

Enrollment Period

2.4 years

First QC Date

February 24, 2012

Last Update Submit

May 23, 2012

Conditions

Community-Acquired Infections

Keywords

severe sepsistoxic shock

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • Opposition of the patient to the IT processing of its data within the framework of this observational study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Rennes University Hospital (Pontchaillou)

Rennes, Ille-et-Vilaine, 35000, France

Location

Brest University Hospital

Brest, 29200, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63003, France

Location

Groupe hospitalier Raymond Poincaré, AP-HP

Garches, 92380, France

Location

Grenoble University Hospital (A. Michallon)

Grenoble, 38048, France

Location

Limoges University Hospital (Hospital Dupuytren)

Limoges, 87042, France

Location

Nancy University Hospital (Jeanne d'Arc)

Nancy, 54201, France

Location

Saint Etienne University Hospital (Bellevue)

Saint-Etienne, 42055, France

Location

Tours University Hospital (Bretonneau)

Tours, 37044, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Non applicable.

MeSH Terms

Conditions

Community-Acquired InfectionsSepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Bellissant Eric, MD, PhD

    Rennes University Hospital - CIC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2012

First Posted

May 28, 2012

Study Start

September 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

May 28, 2012

Record last verified: 2012-04

Locations

FR(9)