PK/PD Study of IN-001 Sublingual Spray in Healthy Adults
NCT07210320
Anaphylaxis, Food Allergy
St Louis, Missouri, United States
View Trial DetailsNCT Number: NCT04290507
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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Notify Me18 year and older
All sexes
Observational
University Hospital of Nancy, Nancy, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 30
The number of participants deceased within ICU hospitalisation
Time frame: Day 30
The volume of fluid administered during priori to and during ICU stay, in millilitres will be noted
Time frame: Day 30
Quantity of epinephrine administered during ICU stay
Time frame: Day 30
Quantity of norepinephrine administered during ICU stay
Time frame: Day 30
The severity of organ failure will be assessed with the SOFA score
Time frame: Day 30
The number of participants that required ECMO V/V or A/V
Central Hospital, Nancy, France
Other
Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit: a French Retrospective Multicenter Study
Acronym: ANAPHYLASHOCK
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View the official ClinicalTrials.gov record (opens in a new tab)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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