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SHARED Study (Saguenay Hospitals Anaphylaxis Rule for Early Discharge)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04755881
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Université de Sherbrooke
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Anaphylaxis, Biphasic Anaphylactic Reaction, Rebound Anaphylactic Reaction
Additional Details

This study is part of an ongoing projet to create, derive and validate a clinical decision rule with regards to the stratification of the biphasic reaction risk following an anaphylaxis event that has mandated an emergency room visit. Phase 0: Systematic literature review (completed) Phase 1: Statistical derivation of two clinical decision rules (retrospective observational study)

  • - (completed) Phase 2: Validation of clinical decision rules (prospective observational study - theoretical) - (underway) Objective: The objective of phase 2 will then be to test the applicability and performance of our clinical decision rules in a prospective observational manner.
Methods: Based on the three clinical decision rules (2 derived from phase 1and one based on the literature review), a prospective observational study will be carried out in the emergency rooms of Chicoutimi, Jonquière and Alma. Data collection for this theoretical validation phase has been underway since December 2019, having received the approval of the various local research committees (ethics, science and convenience). A questionnaire was developed from the three rules derived in the previous phases. All the elements present in these rules have been grouped by categories (history, allergen, symptoms and treatment). In this way, the criteria for each rule were not placed one after the other so that no rule could be recognized or inferred. This questionnaire was presented during department meetings. It is placed on the charts of patients with suspected anaphylaxis at triage and also is available at strategic locations in all three emergency rooms (for example, in the reanimation room). Doctors are therefore invited to complete the questionnaire anonymously following their initial management of an anaphylactic reaction. Thereafter, they treat the patient as they would have done according to their usual practice. No rules is applied to the patients and the answers provided have no impact on their future care. The questionnaires are then deposited in a secured location determined for this purpose, in each of the emergencies. The collection of files began in December 2019 and is still ongoing. The inclusion and exclusion criteria were the same as in phase 1. However, a patient who did not yet meet the criteria for anaphylaxis, but who, according to the clinician's assessment, would inevitably progress to an anaphylactic reaction could also be included if treated in this way. This is then clearly indicated on the questionnaire. At the end of the preliminary recruitment period, all completed questionnaire files will be reviewed to determine if a biphasic reaction has occurred. The three clinical decision rules will then be applied to the population to test their performance, validity and safety. It will also be of interest to assess the number of patients who could have been safely discharged without an observation period if each of the rules had hypothetically been applied. This analysis will also be carried out. Lastly, the investigators propose to run a phase 3 trial, if the phase 2 trial identifies valid and clinically usable clinical decision rule(s). That phase 3 trial will aim to prospectively validate in real clinical setting and in a different patient population subset the selected rule(s).

Arms & Interventions

Arms

: 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.

Interventions

Other: - Occurence of biphasic reaction following anaphylaxis

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).

Contact a Trial Team

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International Sites

Saguenay, Quebec, Canada

Status

Recruiting

Address

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

Saguenay, Quebec, G7H 5H6

Site Contact

Antoine Herman-Lemelin, MD

antoine.herman-lemelin@usherbrooke.ca

(418) 550-0692

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