SHARED Study (Saguenay Hospitals Anaphylaxis Rule for Early Discharge)

NCT04755881 | Terminated

• 1 other identifier: USherbrooke-SHARED-medfam
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 1

Brief Summary

Anaphylaxis is a potentially fatal condition with a prevalence between 0.05 and 2% in the general population. This is therefore a frequent reason for emergency visits. Its diagnosis is mainly based on the NIAID / FAAN2 criteria, developed in 2006. The treatment of the condition consists of administration of intramuscular (or intravenous) epinephrine and the hemodynamic support of the patient, if necessary. Various other agents are frequently administered (class I and II antihistamines, corticosteroids) but their role is recognized to be less central than that of epinephrine. The relevance of corticosteroids in reducing the risk of rebound reaction is even questioned. After anaphylaxis, a serious phenomenon called a "biphasic reaction" can occur. This reaction is the return of symptoms of anaphylaxis resolution of the initial episode. The theoretical risk of a rebound reaction, or biphasic reaction, is conventionally described up to 72 hours after the initial anaphylactic event. Biphasic reaction is defined as a recurrence or occurrence of new signs or symptoms after resolution of the initial reaction, without re-exposure to the allergen. The potential occurrence of a biphasic reaction often warrants observation of patients for several hours in emergency departments following management of the initial anaphylaxis. Although recommendations and guidelines generally suggest observation times of four to six hours, there is no clear consensus or convincing evidence to guide this conduct. It sometimes even is suggested to observe patients for up to 24 hours. Problem: To date, there are no prognostic factors to identify a patient at greater risk who would benefit from such an observation. As these reactions are a relatively rare phenomenon (i.e. 4 to 5%, but which could go up to 20% according to some sources and the symptoms observed are usually less significant than during the initial presentation, it is therefore possible that a prolonged observation period may not be necessary for some patients who do not have high risk factors for biphasic reaction. In the current context of the growing number of people in emergency rooms and limited ressources, it seems essential to identify low risk patients in order to discharge them quicker and safely by limiting unnecessary observation periods. Objective: Identify and evaluate in a prospective manner previously derived (literature review and preliminary rules derivation already completed) clinical decision rules that are simple, generalizable and valid which could therefore become an interesting assets for the modern practice of emergency medicine as regards to post anaphylaxis rebound reaction risk stratification. It appears likely that some patients who have suffered an anaphylactic reaction could be safely discharged much earlier than in current practices. The rules would give clear guidelines to clinicians especially those working in lower flow settings, where clinical experience with the disease is less developed. Ultimately, these rules would also be relevant for teaching purposes for the various learners who do internships in emergency rooms.

Conditions

Anaphylaxis; Biphasic Anaphylactic Reaction; Rebound Anaphylactic Reaction

Keywords

biphasic anaphylactic reaction; anaphylaxis; allergic reaction; clinical decision rule; anaphylactic reaction; predictors of biphasic anaphylactic reaction; epinephrin; anaphylaxis NIAID/FAAN

Outcome Measures

Primary Outcomes (1)

• Rules maintain their sensitivity and negative predictive value with a different sample of patients from the same population pool (prospectively).

  This phase 2 aims to prospectively verify whether these previously derived or inferred rules maintain their sensitivity and negative predictive value with a different sample of patients from the same population pool. The first rule assesses the probability of clinically significant biphasic reactions (sensitivity of 90% in derivation phase, 7 variables) and the second, all biphasic reactions (sensitivity 100% in derivation phase, 7 variable sensitivity). This will allow us to assess the internal validity of the different rules derived from the same three study sites (Chicoutimi, Jonquière, Alma). In addition, the evaluation of the results will help identify the most effective rule.

  December 2019 - 2022

Study Arms (1)

All anaphylaxis reactions seen during the phase 2 period of the SHARED study.

All patients presenting to the 3 sites emergency departments (Chicoutimi, Alma, Jonquière) diagnosed with an anaphylactic reaction or a severe allergic reaction that is rapidly evolving towards anaphylaxis in the opinion of the treating physician.

Other: Occurence of biphasic reaction following anaphylaxis

Interventions

Occurence of biphasic reaction following anaphylaxis OTHER

Prospective observation for biphasic reaction following anaphylaxis and subsequent analysis (comparison between usual care and the care that would have been suggested by the three proposed clinical decision rules).

All anaphylaxis reactions seen during the phase 2 period of the SHARED study.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study aims to recruit 533 patients of all ages from three sites of Saguenay-Lac-St-Jean's hospitals' emercgency services (Chicoutimi, Alma and Jonquiere). Recruiting started in december 2019 following approval from the ethics comity, sciencitic validity evaluation and institutional convenience. Faced with a case of anaphylaxis, the emergency doctor will have to answer a short questionnaire developed with the variables present in each of the three rules.

You may qualify if:

• Patients of all ages with anaphylaxis (meeting the NIAID/FAAN criteria)
• Patients of all ages considered to be inevitably evolving torwards overt anaphylaxis by the threading physician

You may not qualify if:

• Adverse reaction to a medication (eg ACEI)
• Hereditary angioedema
• Known immune mediated Angioedema
• Anaphylactoid reaction

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Service d'urgence CIUSSS du Saguenay - Lac-St-Jean

Saguenay, Quebec, G7H 5H6, Canada

Location

Related Publications (53)

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• Shaker MS, Wallace DV, Golden DBK, Oppenheimer J, Bernstein JA, Campbell RL, Dinakar C, Ellis A, Greenhawt M, Khan DA, Lang DM, Lang ES, Lieberman JA, Portnoy J, Rank MA, Stukus DR, Wang J; Collaborators, Riblet N, Bobrownicki AMP, Bontrager T, Dusin J, Foley J, Frederick B, Fregene E, Hellerstedt S, Hassan F, Hess K, Horner C, Huntington K, Kasireddy P, Keeler D, Kim B, Lieberman P, Lindhorst E, McEnany F, Milbank J, Murphy H, Pando O, Patel AK, Ratliff N, Rhodes R, Robertson K, Scott H, Snell A, Sullivan R, Trivedi V, Wickham A; Chief Editors, Shaker MS, Wallace DV; Workgroup Contributors, Shaker MS, Wallace DV, Bernstein JA, Campbell RL, Dinakar C, Ellis A, Golden DBK, Greenhawt M, Lieberman JA, Rank MA, Stukus DR, Wang J; Joint Task Force on Practice Parameters Reviewers, Shaker MS, Wallace DV, Golden DBK, Bernstein JA, Dinakar C, Ellis A, Greenhawt M, Horner C, Khan DA, Lieberman JA, Oppenheimer J, Rank MA, Shaker MS, Stukus DR, Wang J. Anaphylaxis-a 2020 practice parameter update, systematic review, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) analysis. J Allergy Clin Immunol. 2020 Apr;145(4):1082-1123. doi: 10.1016/j.jaci.2020.01.017. Epub 2020 Jan 28. PMID: 32001253.

  RESULT

MeSH Terms

Conditions

Anaphylaxis; Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, CCFP-ER, MI CPOCUS, Clinical Professor Sherbrooke University

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 16, 2021
• Study Start: December 3, 2019
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

CA (1)