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

Histamine infusion in healthy volunteers to study changes in biomarkers and effects of therapeutic interventions – a pilot study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11335622

Enrollment

Registered

2024-08-05

Start date

2024-08-15

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shock Other

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers

Exclusion criteria

Exclusion criteria: 1. Non-healthy 2. Pregnant 3. Breastfeeding

Design outcomes

Primary

Measure	Time frame
Mean arterial blood pressure measured with an automated device over 15 minutes during histamine infusion	—

Secondary

Measure	Time frame
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	—

Countries

Austria

Contacts

Public ContactBernd Jilma

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026