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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,444
- 试验地点
- 9
- 主要终点
- The primary outcome is the occurrence of severe sepsis, moving toward or away from septic shock.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
The primary outcome is the occurrence of severe sepsis, moving toward or away from septic shock.
时间窗: 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.
次要结局
未报告次要终点