Observational Study on Intubation in Septic Shock

Septic Shock Clinical Trial

— INTUBATIC  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780466
• Other study ID #: 2015-96
• Status: Completed
• First received: May 19, 2016
• Last updated: April 17, 2018
• Start date: May 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 859
• Est. completion date: April 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death		28 days after ICU admission
Secondary	duration of organ support	mechanical ventilation, vasopressors, renal replacement therapy	28 days
Secondary	impact of intubation delay on outcome		28 days