跳至主要内容
临床试验/NCT04755881
NCT04755881终止不适用

SHARED (Saguenay Hospitals Anaphylaxis Rule for Early Discharge) - Phase 2 : a Prospective Theoretical Validation

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 191 人开始时间: 2019年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
191
试验地点
1
主要终点
Rules maintain their sensitivity and negative predictive value with a different sample of patients from the same population pool (prospectively).

研究概览

简要总结

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.

详细描述

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) - (Prematurely terminated)

Objective: The objective of phase 2 was to test the applicability and performance of our clinical decision rules in a prospective observational manner.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: December 2019 - 2022

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antoine Herman-Lemelin

Principal Investigator, CCFP-ER, MI CPOCUS, Clinical Professor Sherbrooke University

Université de Sherbrooke

研究点 (1)

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