AnaphylaxisSHAREDNCT04755881
SHARED Study (Saguenay Hospitals Anaphylaxis Rule for Early Discharge)
An observational study of Anaphylaxis and Biphasic Anaphylactic Reaction, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anaphylaxis, Biphasic Anaphylactic Reaction, Rebound Anaphylactic Reaction
- What is being tested?
- Occurence of biphasic reaction following anaphylaxis
- How many people
- 191 participants
- Where
- 1 siteCanada
- Study dates
- 3 Dec 2019to 7 Mar 2023
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Adverse reaction to a medication (eg ACEI)
- Hereditary angioedema
- Known immune mediated Angioedema
- Anaphylactoid reaction
Trial locations and contacts
1 site in 1 country.
Canada1 site
Service d'urgence CIUSSS du Saguenay - Lac-St-Jean
Saguenay, Quebec, G7H 5H6
About this study
Official title: SHARED (Saguenay Hospitals Anaphylaxis Rule for Early Discharge) - Phase 2 : a Prospective Theoretical Validation
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.
Read more
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.
Read the detailed description
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.
UPDATE (March 2023) This unfortunately failed, the rule showed underperformance and clinical utility wasn't attained / maintained in the derivation phase. Furthermore, we tried combining data for the derivation study (phase 1) and the validation study (phase 2) and found that since the phenomenon of biphasic reaction was so heterogeneous, we would need to recruit an unrealistic number of anaphylaxis cases. This endeavor for which we have nor the time, nor the ressources and nor the organizational capabilities would also statistically lead to a clinical decision rule still subject to failure in its further external validations because of the very heterogeneous nature of allergens and the subjects immune reactions to them (projected frailty index).
Methods: Based on the three clinical decision rules (2 derived from phase 1and one based on the literature review), a prospective observational study was carried out in the emergency rooms of Chicoutimi, Jonquière and Alma. Data collection for this theoretical validation phase has been underway since December 2019 and stopped in march 2023, 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 were 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 was applied to the patients and the answers provided had no impact on their future care. The questionnaires were 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 now terminated. 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 was 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. The planned interim analysis which led to preliminary termination of the study included 191 cases of anaphylaxis and 11 biphasic reactions (only 6 of which were deemed clinically significant as per protocol criteria).
Some number of anaphylaxis cases were included in the study in between the preliminary analysis (march 2022) and its the results and decision to terminate the study (march 2023). This remaining will of course be analyzed and we propose to publish our data sets in hopes it can be used by other researchers in the field.
Lastly, the investigators were proposing to run a phase 3 trial, if the phase 2 trial had identified valid and clinically usable clinical decision rule(s). That phase 3 trial would have aimed to prospectively validate in real clinical setting and in a different patient population subset the selected rule(s). This phase 3 will unfortunately not be taking place as the trial was prematurely terminated during planned interim analysis in its phase 2 due to clinical uselessness of all 3 rules being tested. Of note, investigators tried to combine data sets from both phases 1 and 2 and still could not derive a rule for which statistical solidity could be expected in the face of such an heterogeneous process as the biphasic allergic reaction is.
- Being tested
- Occurence of biphasic reaction following anaphylaxis
- Keywords
- biphasic anaphylactic reaction, anaphylaxis, allergic reaction, clinical decision rule, anaphylactic reaction, predictors of biphasic anaphylactic reaction, epinephrin, anaphylaxis NIAID/FAAN
- Medical subject headings
- Anaphylaxis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occurence of biphasic reaction following anaphylaxisOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Occurence of biphasic reaction following anaphylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: December 2019 - 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start3 Dec 2019
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Why it stopped: Planned interim data analysis showed underperformance (statistical and clinical) of the three derived clinical decision rules that had been derived and that we were trying to validate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for AnaphylaxisStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine Herman-Lemelin, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755881
- Sponsor's protocol ID
- USherbrooke-SHARED-medfam
- Acronym
- SHARED
- Status last verified
- Mar 2023
- First submitted
- 1 Feb 2021
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Campbell and al., Anaphylaxis: Emergency treatment. UptoDate. 2018
Lieberman, P. and al. Biphasic and protracted anaphylaxis. UptoDate. 2018
Lieberman P, Nicklas RA, Randolph C, Oppenheimer J, Bernstein D, Bernstein J, Ellis A, Golden DB, Greenberger P, Kemp S, Khan D, Ledford D, Lieberman J, Metcalfe D, Nowak-Wegrzyn A, Sicherer S, Wallace D, Blessing-Moore J, Lang D, Portnoy JM, Schuller D, Spector S, Tilles SA. Anaphylaxis--a practice parameter update 2015. Ann Allergy Asthma Immunol. 2015 Nov;115(5):341-84. doi: 10.1016/j.anai.2015.07.019. No abstract available.
PubMed 26505932Alqurashi W, Ellis AK. Do Corticosteroids Prevent Biphasic Anaphylaxis? J Allergy Clin Immunol Pract. 2017 Sep-Oct;5(5):1194-1205. doi: 10.1016/j.jaip.2017.05.022.
PubMed 28888249Simons FE, Ebisawa M, Sanchez-Borges M, Thong BY, Worm M, Tanno LK, Lockey RF, El-Gamal YM, Brown SG, Park HS, Sheikh A. 2015 update of the evidence base: World Allergy Organization anaphylaxis guidelines. World Allergy Organ J. 2015 Oct 28;8(1):32. doi: 10.1186/s40413-015-0080-1. eCollection 2015.
PubMed 26525001Surveillance report 2016 - Anaphylaxis: assessment and referral after emergency treatment (2011) NICE guideline CG134 [Internet]. London: National Institute for Health and Care Excellence (NICE); 2016 Nov 10. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK551072/
PubMed 31855336Brown SG, Stone SF, Fatovich DM, Burrows SA, Holdgate A, Celenza A, Coulson A, Hartnett L, Nagree Y, Cotterell C, Isbister GK. Anaphylaxis: clinical patterns, mediator release, and severity. J Allergy Clin Immunol. 2013 Nov;132(5):1141-1149.e5. doi: 10.1016/j.jaci.2013.06.015. Epub 2013 Aug 1.
PubMed 23915715Zilberstein J, McCurdy MT, Winters ME. Anaphylaxis. J Emerg Med. 2014 Aug;47(2):182-7. doi: 10.1016/j.jemermed.2014.04.018. Epub 2014 Jun 2.
PubMed 24881890Campbell RL, Li JT, Nicklas RA, Sadosty AT; Members of the Joint Task Force; Practice Parameter Workgroup. Emergency department diagnosis and treatment of anaphylaxis: a practice parameter. Ann Allergy Asthma Immunol. 2014 Dec;113(6):599-608. doi: 10.1016/j.anai.2014.10.007. No abstract available.
PubMed 25466802Cheng A. Emergency treatment of anaphylaxis in infants and children. Paediatr Child Health. 2011 Jan;16(1):35-40.
PubMed 22211074Ring J, Beyer K, Biedermann T, Bircher A, Duda D, Fischer J, Friedrichs F, Fuchs T, Gieler U, Jakob T, Klimek L, Lange L, Merk HF, Niggemann B, Pfaar O, Przybilla B, Ruëff F, Rietschel E, Schnadt S, Seifert R, Sitter H, Varga EM, Worm M, Brockow K. Guideline for acute therapy and management of anaphylaxis: S2 Guideline of the German Society for Allergology and Clinical Immunology (DGAKI), the Association of German Allergologists (AeDA), the Society of Pediatric Allergy and Environmental Medicine (GPA), the German Academy of Allergology and Environmental Medicine (DAAU), the German Professional Association of Pediatricians (BVKJ), the Austrian Society for Allergology and Immunology (ÖGAI), the Swiss Society for Allergy and Immunology (SGAI), the German Society of Anaesthesiology and Intensive Care Medicine (DGAI), the German Society of Pharmacology (DGP), the German Society for Psychosomatic Medicine (DGPM), the German Working Group of Anaphylaxis Training and Education (AGATE) and the patient organization German Allergy and Asthma Association (DAAB). Allergo J Int. 2014;23(3):96-112. doi: 10.1007/s40629-014-0009-1. PMID: 26120521; PMCID: PMC4479483.
Simons FE, Ardusso LR, Bilo MB, Cardona V, Ebisawa M, El-Gamal YM, Lieberman P, Lockey RF, Muraro A, Roberts G, Sanchez-Borges M, Sheikh A, Shek LP, Wallace DV, Worm M. International consensus on (ICON) anaphylaxis. World Allergy Organ J. 2014 May 30;7(1):9. doi: 10.1186/1939-4551-7-9. eCollection 2014.
PubMed 24920969Waserman S, Chad Z, Francoeur MJ, Small P, Stark D, Vander Leek TK, Kaplan A, Kastner M. Management of anaphylaxis in primary care: Canadian expert consensus recommendations. Allergy. 2010 Sep;65(9):1082-92. doi: 10.1111/j.1398-9995.2010.02418.x. Epub 2010 Jun 24.
PubMed 20584005Muraro A, Roberts G, Simons FE. New visions for anaphylaxis: an iPAC summary and future trends. Pediatr Allergy Immunol. 2008 Aug;19 Suppl 19:40-50. doi: 10.1111/j.1399-3038.2008.00766.x.
PubMed 18665962Chipps BE. Update in pediatric anaphylaxis: a systematic review. Clin Pediatr (Phila). 2013 May;52(5):451-61. doi: 10.1177/0009922812474683. Epub 2013 Feb 7.
PubMed 23393309
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHARED (Saguenay Hospitals Anaphylaxis Rule for Early Discharge) - Phase 2 : a Prospective Theoretical Validation
- ClinicalTrials.gov ID
- NCT04755881
- Acronym / sponsor ID
- SHARED / USherbrooke-SHARED-medfam
- Keywords
- biphasic anaphylactic reaction, anaphylaxis, allergic reaction, clinical decision rule, anaphylactic reaction, predictors of biphasic anaphylactic reaction, epinephrin, anaphylaxis NIAID/FAAN
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Planned interim data analysis showed underperformance (statistical and clinical) of the three derived clinical decision rules that had been derived and that we were trying to validate.
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
UPDATE (March 2023) This unfortunately failed, the rule showed underperformance and clinical utility wasn't attained / maintained in the derivation phase. Furthermore, we tried combining data for the derivation study (phase 1) and the validation study (phase 2) and found that since the phenomenon of biphasic reaction was so heterogeneous, we would need to recruit an unrealistic number of anaphylaxis cases. This endeavor for which we have nor the time, nor the ressources and nor the organizational capabilities would also statistically lead to a clinical decision rule still subject to failure in its further external validations because of the very heterogeneous nature of allergens and the subjects immune reactions to them (projected frailty index).
Methods: Based on the three clinical decision rules (2 derived from phase 1and one based on the literature review), a prospective observational study was carried out in the emergency rooms of Chicoutimi, Jonquière and Alma. Data collection for this theoretical validation phase has been underway since December 2019 and stopped in march 2023, 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 were 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 was applied to the patients and the answers provided had no impact on their future care. The questionnaires were 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 now terminated. 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 was 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. The planned interim analysis which led to preliminary termination of the study included 191 cases of anaphylaxis and 11 biphasic reactions (only 6 of which were deemed clinically significant as per protocol criteria).
Some number of anaphylaxis cases were included in the study in between the preliminary analysis (march 2022) and its the results and decision to terminate the study (march 2023). This remaining will of course be analyzed and we propose to publish our data sets in hopes it can be used by other researchers in the field.
Lastly, the investigators were proposing to run a phase 3 trial, if the phase 2 trial had identified valid and clinically usable clinical decision rule(s). That phase 3 trial would have aimed to prospectively validate in real clinical setting and in a different patient population subset the selected rule(s). This phase 3 will unfortunately not be taking place as the trial was prematurely terminated during planned interim analysis in its phase 2 due to clinical uselessness of all 3 rules being tested. Of note, investigators tried to combine data sets from both phases 1 and 2 and still could not derive a rule for which statistical solidity could be expected in the face of such an heterogeneous process as the biphasic allergic reaction is.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All anaphylaxis reactions seen during the phase 2 period of the SHARED study. | – | Other: Occurence of biphasic reaction following anaphylaxisAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Adverse reaction to a medication (eg ACEI)
- Hereditary angioedema
- Known immune mediated Angioedema
- Anaphylactoid reaction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occurence of biphasic reaction following anaphylaxisProspective 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). | Other | All anaphylaxis reactions seen during the phase 2 period of the SHARED study. |
Primary outcome
Rules maintain their sensitivity and negative predictive value with a different sample of patients from the same population pool (prospectively).
Time frame: 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.
Results and safety
The study was stopped early (reason given: Planned interim data analysis showed underperformance (statistical and clinical) of the three derived clinical decision rules that had been derived and that we were trying to validate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- BackgroundCampbell and al., Anaphylaxis: Emergency treatment. UptoDate. 2018
- BackgroundLieberman, P. and al. Biphasic and protracted anaphylaxis. UptoDate. 2018
- Background: PubMed 26505932Lieberman P, Nicklas RA, Randolph C, Oppenheimer J, Bernstein D, Bernstein J, Ellis A, Golden DB, Greenberger P, Kemp S, Khan D, Ledford D, Lieberman J, Metcalfe D, Nowak-Wegrzyn A, Sicherer S, Wallace D, Blessing-Moore J, Lang D, Portnoy JM, Schuller D, Spector S, Tilles SA. Anaphylaxis--a practice parameter update 2015. Ann Allergy Asthma Immunol. 2015 Nov;115(5):341-84. doi: 10.1016/j.anai.2015.07.019. No abstract available.
- Background: PubMed 28888249Alqurashi W, Ellis AK. Do Corticosteroids Prevent Biphasic Anaphylaxis? J Allergy Clin Immunol Pract. 2017 Sep-Oct;5(5):1194-1205. doi: 10.1016/j.jaip.2017.05.022.
- Background: PubMed 26525001Simons FE, Ebisawa M, Sanchez-Borges M, Thong BY, Worm M, Tanno LK, Lockey RF, El-Gamal YM, Brown SG, Park HS, Sheikh A. 2015 update of the evidence base: World Allergy Organization anaphylaxis guidelines. World Allergy Organ J. 2015 Oct 28;8(1):32. doi: 10.1186/s40413-015-0080-1. eCollection 2015.
- Background: PubMed 31855336Surveillance report 2016 - Anaphylaxis: assessment and referral after emergency treatment (2011) NICE guideline CG134 [Internet]. London: National Institute for Health and Care Excellence (NICE); 2016 Nov 10. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK551072/
- Background: PubMed 23915715Brown SG, Stone SF, Fatovich DM, Burrows SA, Holdgate A, Celenza A, Coulson A, Hartnett L, Nagree Y, Cotterell C, Isbister GK. Anaphylaxis: clinical patterns, mediator release, and severity. J Allergy Clin Immunol. 2013 Nov;132(5):1141-1149.e5. doi: 10.1016/j.jaci.2013.06.015. Epub 2013 Aug 1.
- Background: PubMed 24881890Zilberstein J, McCurdy MT, Winters ME. Anaphylaxis. J Emerg Med. 2014 Aug;47(2):182-7. doi: 10.1016/j.jemermed.2014.04.018. Epub 2014 Jun 2.
- Background: PubMed 25466802Campbell RL, Li JT, Nicklas RA, Sadosty AT; Members of the Joint Task Force; Practice Parameter Workgroup. Emergency department diagnosis and treatment of anaphylaxis: a practice parameter. Ann Allergy Asthma Immunol. 2014 Dec;113(6):599-608. doi: 10.1016/j.anai.2014.10.007. No abstract available.
- Background: PubMed 22211074Cheng A. Emergency treatment of anaphylaxis in infants and children. Paediatr Child Health. 2011 Jan;16(1):35-40.
- BackgroundRing J, Beyer K, Biedermann T, Bircher A, Duda D, Fischer J, Friedrichs F, Fuchs T, Gieler U, Jakob T, Klimek L, Lange L, Merk HF, Niggemann B, Pfaar O, Przybilla B, Ruëff F, Rietschel E, Schnadt S, Seifert R, Sitter H, Varga EM, Worm M, Brockow K. Guideline for acute therapy and management of anaphylaxis: S2 Guideline of the German Society for Allergology and Clinical Immunology (DGAKI), the Association of German Allergologists (AeDA), the Society of Pediatric Allergy and Environmental Medicine (GPA), the German Academy of Allergology and Environmental Medicine (DAAU), the German Professional Association of Pediatricians (BVKJ), the Austrian Society for Allergology and Immunology (ÖGAI), the Swiss Society for Allergy and Immunology (SGAI), the German Society of Anaesthesiology and Intensive Care Medicine (DGAI), the German Society of Pharmacology (DGP), the German Society for Psychosomatic Medicine (DGPM), the German Working Group of Anaphylaxis Training and Education (AGATE) and the patient organization German Allergy and Asthma Association (DAAB). Allergo J Int. 2014;23(3):96-112. doi: 10.1007/s40629-014-0009-1. PMID: 26120521; PMCID: PMC4479483.
- Background: PubMed 24920969Simons FE, Ardusso LR, Bilo MB, Cardona V, Ebisawa M, El-Gamal YM, Lieberman P, Lockey RF, Muraro A, Roberts G, Sanchez-Borges M, Sheikh A, Shek LP, Wallace DV, Worm M. International consensus on (ICON) anaphylaxis. World Allergy Organ J. 2014 May 30;7(1):9. doi: 10.1186/1939-4551-7-9. eCollection 2014.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
Related trials for Anaphylaxis
Active, not recruitingPhase 2
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
Peanut Allergy, Peanut Hypersensitivity
RecruitingObservational study
Maximum Lysis on Thromboelastography as a Marker of Systemic Severity in Acute Allergic Reactions
Allergy, Allergic Reactions
Not yet recruitingPhase 2
Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients
Epinephrine, Hypersensitivity, Immediate
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
RecruitingObservational study
Post-market Safety Study of LUMISIGHT
Hypersensitivity Reactions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaphylaxis and Biphasic Anaphylactic Reaction, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Planned interim data analysis showed underperformance (statistical and clinical) of the three derived clinical decision rules that had been derived and that we were trying to validate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rules maintain their sensitivity and negative predictive value with a different sample of patients from the same population pool (prospectively). (time frame: December 2019 - 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04755881, which also lists 53 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.