NCT04290507

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
339

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

January 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
Last Updated

March 11, 2020

Status Verified

February 1, 2020

Enrollment Period

2.5 years

First QC Date

February 27, 2020

Last Update Submit

March 9, 2020

Conditions

Keywords

fluid managementmortality

Outcome Measures

Primary Outcomes (1)

  • In-ICU mortality

    The number of participants deceased within ICU hospitalisation

    Day 30

Secondary Outcomes (5)

  • Volume of fluid administered

    Day 30

  • Amount of epinephrine

    Day 30

  • Amount of norepinephrine

    Day 30

  • Number and severity of organ failure

    Day 30

  • Extracorporeal life support requirement

    Day 30

Eligibility Criteria

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

All patients admitted to ICU following anaphylaxis

You may qualify if:

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

You may not qualify if:

  • dead within less than one hour after admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Nancy

Nancy, 54511, France

Location

University Hospital of Strasbourg

Strasbourg, France

Location

Related Publications (1)

  • Guerci P, Tacquard C, Chenard L, Millard D, Soufir L, Malinovsky JM, Garot M, Lalot JM, Besch G, Louis G, Thion LA, Charpentier C, Kimmoun A, Danguy Des Deserts M, Carreira S, Plantefeve G, Novy E, Abraham P, Mertes PM; Societe Francaise d'Anesthesie et Reanimation (SFAR) Research Network. Epidemiology and outcome of patients admitted to intensive care after anaphylaxis in France: a retrospective multicentre study. Br J Anaesth. 2020 Dec;125(6):1025-1033. doi: 10.1016/j.bja.2020.08.024. Epub 2020 Sep 12.

MeSH Terms

Conditions

Anaphylaxis

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 2, 2020

Study Start

January 1, 2017

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

March 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations