Observational Study on Intubation in Septic Shock

Completed

• Conditions: Septic Shock

• Registration Number: NCT02780466
• Lead Sponsor: University Hospital, Angers

Brief Summary

Septic shock is common in intensive care and its mortality remains high. While new treatments have not improved survival, optimization of known and widely used techniques has allowed reduction in mortality. Thus improving care given to patients starts with making better use of existing resuscitation techniques. Among these practices, mechanical ventilation is widespread in the management of patients with septic shock. In large studies published in recent years in Europe and North America, 40 to 85% of patients receive invasive mechanical ventilation. It therefore appears that a significant proportion of patients are never intubated during treatment and management of their septic shock. There is no specific recommendation from critical care societies concerning mechanical ventilation in the treatment of septic shock. Apart from indisputable situations such as impaired consciousness or acute respiratoire distress, the decision whether to ventilate mechanically or not is left to the discretion of the physician.

The aim of this study is to analyze intubation practice in septic shock patients and its impact on 28-day survival.

This multicentric and observational study will be conducted in 30 French ICUs.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-23
• Primary Completion: 2017-10
• Status Verified: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 859

Inclusion Criteria

• older than 18 years old
• Admitted in the ICU for septic shock
• Introduction of vasopressors ( norepinephrine or adrenaline ) in the ICU or within 24 hours of ICU admission
• Suspected or proven infection

Exclusion Criteria

• Intubation before the introduction of vasopressors
• Decision of withdrawing or withholding care at admission
• Pregnant woman
• Patient not affiliated to the social security insurance
• Refusal of participation in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
death	28 days after ICU admission

Secondary Outcome Measures

Name	Time	Method
duration of organ support	28 days	mechanical ventilation, vasopressors, renal replacement therapy
impact of intubation delay on outcome	28 days