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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Definition of cases:
Definition of controls:
Non inclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bellissant Eric, MD, PhD | Rennes University Hospital - CIC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes University Hospital (Pontchaillou) | Rennes | Ille-et-Vilaine | 35000 | France | ||
| Brest University Hospital |
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| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Non applicable.
| Brest |
| 29200 |
| France |
| Clermont-Ferrand University Hospital | Clermont-Ferrand | 63003 | France |
| Groupe hospitalier Raymond Poincaré, AP-HP | Garches | 92380 | France |
| Grenoble University Hospital (A. Michallon) | Grenoble | 38048 | France |
| Limoges University Hospital (Hospital Dupuytren) | Limoges | 87042 | France |
| Nancy University Hospital (Jeanne d'Arc) | Nancy | 54201 | France |
| Saint Etienne University Hospital (Bellevue) | Saint-Etienne | 42055 | France |
| Tours University Hospital (Bretonneau) | Tours | 37044 | France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |