Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit

Completed

• Conditions: Anaphylaxis

• Registration Number: NCT04290507
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, accompanied with an increased number of hospitalizations. Although rare, this condition is often associated with a significant morbidity and mortality. The mortality rate has been recently estimated at 0.84 (95% CI, 0.79 to 0.88) per million per year in the French adult population. Age, chronic medication and cardiac or pulmonary comorbidities have been reported to increase the risk of a severe reaction. Obesity, age and cardiovascular comorbidities have been identified as risk factors for fatal anaphylaxis. However, the risk factors for death after ICU admission have not been elucidated yet.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-02
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 339

Inclusion Criteria

• Being > 18 years old
• suffered an anaphylactic reaction, regardless of the location or causative allergen
• transferred alive in an ICU

Exclusion Criteria

• dead within less than one hour after admission

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-ICU mortality	Day 30	The number of participants deceased within ICU hospitalisation

Secondary Outcome Measures

Name	Time	Method
Amount of epinephrine	Day 30	Quantity of epinephrine administered during ICU stay
Amount of norepinephrine	Day 30	Quantity of norepinephrine administered during ICU stay
Number and severity of organ failure	Day 30	The severity of organ failure will be assessed with the SOFA score
Volume of fluid administered	Day 30	The volume of fluid administered during priori to and during ICU stay, in millilitres will be noted
Extracorporeal life support requirement	Day 30	The number of participants that required ECMO V/V or A/V

Trial Locations

Locations (2)

University Hospital of Nancy; 🇫🇷 Nancy, France

University Hospital of Strasbourg; 🇫🇷 Strasbourg, France