Investigating the effects of recommended - but unproven - therapies for anaphylaxis in a human histamine challenge model

ISRCTN ISRCTN11335622
DOI https://doi.org/10.1186/ISRCTN11335622
EudraCT/CTIS number 2022-003591-16
Submission date
02/08/2024
Registration date
05/08/2024
Last edited
05/08/2024
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Anaphylaxis is a life-threatening allergic reaction that happens very quickly. Epinephrine and other interventions are recommended for the treatment of anaphylaxis. However, there is no evidence for effectiveness from randomized controlled trials. The aim of this trial is to compare the treatments recommended in anaphylaxis guidelines in a randomised controlled trial in healthy volunteers challenged with histamine.

Who can participate?
Healthy volunteers aged 18 years and over

What does the study involve?
Healthy volunteers will undergo a histamine challenge to lower blood pressure in order to test interventions that may raise blood pressure (injections of adrenaline, infusion of fluid and elevation of legs).

What are the possible benefits and risks of participating?
As histamine has rapidly reversible actions the risks are limited mainly to blood sampling and side effects such as flushing and headache. There will be no direct benefit for the participants other than information form the performed health tests.

Where is the study run from?
Medical University of Vienna (Austria)

When is the study starting and how long is it expected to run for?
March 2022 to January 2030

Who is funding the study?
Investigator initiated funding not yet secured

Who is the main contact?
Prof. Bernd Jilma, MD, bernd.jilma@meduniwien.ac.at

Contact information

Prof Bernd Jilma
Public, Scientific, Principal Investigator

Währingergürtel 18-20
Vienna
1090
Austria

Phone +43 (0)40400-29810
Email bernd.jilma@meduniwien.ac.at

Study information

Study designPartly randomized controlled trial
Primary study designInterventional
Secondary study designPartly randomized adaptive trial
Study setting(s)Hospital
Study typeTreatment, Efficacy
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleHistamine infusion in healthy volunteers to study changes in biomarkers and effects of therapeutic interventions – a pilot study
Study acronymEPI/HIS
Study objectivesHistamine challenge can be used as a surrogate to examine therapies to treat anaphylaxis
Ethics approval(s)

Approved 21/03/2022, Medical University of Vienna (Borschkegasse, VIenna, 1090, Austria; +43 (0)140400; ethik-kom@meduniwien.ac.at), ref: IRB00002503

Health condition(s) or problem(s) studiedShock
InterventionRecommended interventions for anaphylaxis treatment; this is part of the adaptive trial design and may change. Additional arms may be added in the platform trial approach

1. Elevation of legs (10 min)
2. Volume of crystalloids 10 ml/kg over 10 min
3. Control injection of placebo (same volume as adrenaline)
4. Adrenaline doses as recommended in current anaphylaxis guidelines
Intervention typeMixed
Primary outcome measureMean arterial blood pressure measured with an automated device over 15 minutes during histamine infusion
Secondary outcome measures1. Diastolic and systolic blood pressure with an automated device measured over 15 minutes during histamine infusion
2. Pharmacokinetics of adrenaline measured with qualified mass spectrometry assays over 60 minutes
Overall study start date21/03/2022
Completion date01/01/2030

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsThe sample size will depend on the observed effect sizes and the variability thereof and can only be determined after the pilot trial has been completed
Key inclusion criteriaHealthy volunteers
Key exclusion criteria1. Non-healthy
2. Pregnant
3. Breastfeeding
Date of first enrolment15/08/2024
Date of final enrolment01/01/2030

Locations

Countries of recruitment

  • Austria

Study participating centre

Medical University of VIenna
Dept of Clinical Pharmacology
Währingergerürtel 18-20
Wien
1090
Austria

Sponsor information

Medical University of Vienna
University/education

Spitalgasse 23
Vienna
1090
Austria

Phone +43 (0)140160-0
Email klin-pharmakologie@meduniwien.ac.at
Website http://www.meduniwien.ac.at/homepage/1/homepage/
ROR logo "ROR" https://ror.org/05n3x4p02

Funders

Funder type

Other

Investigator initiated funding not yet secured

No information available

Results and Publications

Intention to publish date01/01/2027
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request, Other
Publication and dissemination planResults will be presented at international conferences and in peer-reviewed journals
IPD sharing planDue to data protection issues, only anonymized data will be shared with qualified researchers. Prof. Bernd Jilma (bernd.jilma@meduniwien.ac.at) should be contacted for access to datasets, anonymized raw data of the primary and secondary endpoints will be shared with qualified investigators once the related manuscripts have been published, and the request has been cleared by the institution’s data protection unit.

Editorial Notes

02/08/2024: Study's existence confirmed by the Federal Office for Safety in Health Care (BASG).