Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit

Anaphylaxis Clinical Trial

— ANAPHYLASHOCK  

Official title:

Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit: a French Retrospective Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04290507
• Other study ID #: ANAPHYLASHOCK/Guerci
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anaphylaxis

Locations

Country	Name	City	State
France	University Hospital of Nancy	Nancy
France	University Hospital of Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-ICU mortality	The number of participants deceased within ICU hospitalisation	Day 30
Secondary	Volume of fluid administered	The volume of fluid administered during priori to and during ICU stay, in millilitres will be noted	Day 30
Secondary	Amount of epinephrine	Quantity of epinephrine administered during ICU stay	Day 30
Secondary	Amount of norepinephrine	Quantity of norepinephrine administered during ICU stay	Day 30
Secondary	Number and severity of organ failure	The severity of organ failure will be assessed with the SOFA score	Day 30
Secondary	Extracorporeal life support requirement	The number of participants that required ECMO V/V or A/V	Day 30