Investigating the effects of recommended - but unproven - therapies for anaphylaxis in a human histamine challenge model
ISRCTN | ISRCTN11335622 |
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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
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
Public, Scientific, Principal Investigator
Währingergürtel 18-20
Vienna
1090
Austria
Phone | +43 (0)40400-29810 |
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bernd.jilma@meduniwien.ac.at |
Study information
Study design | Partly randomized controlled trial |
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Primary study design | Interventional |
Secondary study design | Partly randomized adaptive trial |
Study setting(s) | Hospital |
Study type | Treatment, Efficacy |
Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
Scientific title | Histamine infusion in healthy volunteers to study changes in biomarkers and effects of therapeutic interventions – a pilot study |
Study acronym | EPI/HIS |
Study objectives | Histamine 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) studied | Shock |
Intervention | Recommended 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 type | Mixed |
Primary outcome measure | Mean arterial blood pressure measured with an automated device over 15 minutes during histamine infusion |
Secondary outcome measures | 1. 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 date | 21/03/2022 |
Completion date | 01/01/2030 |
Eligibility
Participant type(s) | Healthy volunteer |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | The 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 criteria | Healthy volunteers |
Key exclusion criteria | 1. Non-healthy 2. Pregnant 3. Breastfeeding |
Date of first enrolment | 15/08/2024 |
Date of final enrolment | 01/01/2030 |
Locations
Countries of recruitment
- Austria
Study participating centre
Währingergerürtel 18-20
Wien
1090
Austria
Sponsor information
University/education
Spitalgasse 23
Vienna
1090
Austria
Phone | +43 (0)140160-0 |
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klin-pharmakologie@meduniwien.ac.at | |
Website | http://www.meduniwien.ac.at/homepage/1/homepage/ |
https://ror.org/05n3x4p02 |
Funders
Funder type
Other
No information available
Results and Publications
Intention to publish date | 01/01/2027 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request, Other |
Publication and dissemination plan | Results will be presented at international conferences and in peer-reviewed journals |
IPD sharing plan | Due 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).