DOI: 10.5281/zenodo.17473119
title: Effect of Intramuscular Adrenaline on Histamine‐Induced Hypotension: A Randomised Placebo‐Controlled Pilot Trial

description: Data from: Effect of Intramuscular Adrenaline on Histamine‐Induced Hypotension: A Randomised Placebo‐Controlled Pilot Trial

Description of the data and file structure

Clinical and demographic data on subjects challenged with intravenous histamine (0.25 to 1 µg/kg/min) for 15 minutes; includes pharmacological intervention data from intramuscular adrenaline/epinephrine and placebo periods where applicable.

Files and variables

File: EPI-HIS_Dataset_Zenodo.xlsxDescription: This Excel workbook contains two Sheets, one for hemodynamic and laboratory parameters and one for adverse events.

Variables

Sheet: EPI_HIS_Dataset  - Subject_ID — individual ID  - Periode — treatment period (0 = Screening/Baseline, 1-4 = different interventional periods)  - Time — minutes relative to start of histamine infusion (= 0 min)  - Intervention — Intervention of respective period (Dose-finding, Adrenaline, Fluids, Leg-Elevation) [see study protocol for interventional procedure]  - Responder — individual with any single timepoint >60 mmHg MAP after adrenaline/Placebo application  - Adrenaline_Dose — in µg  - HIS-dose — in µg/kg/min  - Exploratory_Confirmatory — part of study  - PR_b/min — bpm  - delta-PR — Delta: value at time t minus baseline; baseline = subject- and period-specific average during −10 to −0.33 min before time zero (t = 0)  - SYS_mmHg — systolic blood pressure in mmHg  - delta-SYS — Delta: value at time t minus baseline; baseline = subject- and period-specific average during −10 to −0.33 min before time zero (t = 0)  - DIA_mmHg — diastolic blood pressure in mmHg  - delta-DIA — Delta: value at time t minus baseline; baseline = subject- and period-specific average during −10 to −0.33 min before time zero (t = 0)  - MAP_mmHg — mean arterial pressure in mmHg  - delta-MAP — Delta: value at time t minus baseline; baseline = subject- and period-specific average during −10 to −0.33 min before time zero (t = 0)  - adrenaline_concentration — plasma adrenaline concentration in pg/mL  - histamine_concentration — plasma histamine concentration in ng/mL  - Hemoglobin — g/dL  - Hematocrit — %  - PLT — platelets ×10^9/L  - WBC — white blood cells ×10^9/L  - Creatinine — mg/dL  - BUN — Blood urea Nitrogen mg/dL  - ALP — Alkaline phosphatase U/L  - AST — Aspartate aminotransferase U/L  - ALT — Alanine aminotransferase U/L  - GGT — Gamma-glutamyl transferase U/L  - LDH — Lactate dehydrogenase U/L  - CRP — C-reactive protein mg/dL  - Tryptase — µg/L (≙ ng/mL)  - Lactate — mmol/L  - CystatinC — mg/L  - Age — ranges (decades)  - Sex — male/female (self-reported)  - BMI — kg/m^2

Sheet: EPI_HIS_Adverse_Events  - Subject-ID — individual ID  - Period — treatment period (0 = Screening/Baseline, 1-4 = different interventional periods)  - Adverse Event   - duration — duration in min from beginning of adverse event  - Severity — (mild = 1, moderate =2, severe = 3)  - Dose change — change of histamine dose due to adverse event  - ConMed — Administration of concomitant medication due to adverse event  - Relationship — 1=definitely, 2=probably, 3=possible, 4=unlikely, 5=not related

Code/software

Data can be opened in Microsoft Excel, LibreOffice Calc, or imported into R/Python (e.g., `readxl`, `pandas`).

Human subjects data and ethics

The study was approved by the Ethics Committee of the Medical University of Vienna (Nr: 1917/2022) and conducted in accordance with Good Clinical Practice (GCP) guidelines and the principles of the Declaration of Helsinki. The study was registered with the Clinical Trials Information System (CTIS), identifier 2022-003591-16, and the UK clinical study registry (ISRCTN11335622). All participants provided written informed consent before any trial-related activity.