NCT02780466

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
859

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

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

May 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.4 years

First QC Date

May 19, 2016

Last Update Submit

April 17, 2018

Conditions

Septic Shock

Keywords

Septic shockEndotracheal intubationOutcome

Outcome Measures

Primary Outcomes (1)

  • death

    28 days after ICU admission

Secondary Outcomes (2)

  • duration of organ support

    28 days

  • impact of intubation delay on outcome

    28 days

Study Arms (1)

Patients with septic shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in the study are adults patients admitted to intensive care unit in France (about 30 centers) for shock, supposed or confirmed of septic origin.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Mellado-Artigas R, Ferrando C, Martino F, Delbove A, Ferreyro BL, Darreau C, Jacquier S, Brochard L, Lerolle N. Early intubation and patient-centered outcomes in septic shock: a secondary analysis of a prospective multicenter study. Crit Care. 2022 Jun 7;26(1):163. doi: 10.1186/s13054-022-04029-6.

    PMID: 35672860DERIVED

  • Darreau C, Martino F, Saint-Martin M, Jacquier S, Hamel JF, Nay MA, Terzi N, Ledoux G, Roche-Campo F, Camous L, Pene F, Balzer T, Bagate F, Lorber J, Bouju P, Marois C, Robert R, Gaudry S, Commereuc M, Debarre M, Chudeau N, Labroca P, Merouani K, Egreteau PY, Peigne V, Bornstain C, Lebas E, Benezit F, Vally S, Lasocki S, Robert A, Delbove A, Lerolle N. Use, timing and factors associated with tracheal intubation in septic shock: a prospective multicentric observational study. Ann Intensive Care. 2020 May 24;10(1):62. doi: 10.1186/s13613-020-00668-6.

    PMID: 32449053DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator for medical research

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 23, 2016

Study Start

May 1, 2016

Primary Completion

October 1, 2017

Study Completion

April 1, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04