Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit (ANAPHYLASHOCK)

March 9, 2020 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

339

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54511
        • University Hospital Of Nancy
      • Strasbourg, France
        • University Hospital of Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to ICU following anaphylaxis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-ICU mortality
Time Frame: Day 30
The number of participants deceased within ICU hospitalisation
Day 30

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANAPHYLASHOCK/Guerci

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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