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Completed

NCT Number: NCT04290507

Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Nancy, Nancy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. In-ICU mortality

    Time frame: Day 30

    The number of participants deceased within ICU hospitalisation

Secondary outcomes

  1. 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

  2. Amount of epinephrine

    Time frame: Day 30

    Quantity of epinephrine administered during ICU stay

  3. Amount of norepinephrine

    Time frame: Day 30

    Quantity of norepinephrine administered during ICU stay

  4. Number and severity of organ failure

    Time frame: Day 30

    The severity of organ failure will be assessed with the SOFA score

  5. Extracorporeal life support requirement

    Time frame: Day 30

    The number of participants that required ECMO V/V or A/V

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: ANAPHYLASHOCK

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 2, 2020
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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