Patients after successful cardiopulmonary resuscitation who undergo target temperature management for 24h hours
Conditions
Interventions
Trade Name: Pantozol
Product Name: Pantoprazole
Product Code: Pantoprazole
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: PANTOPRAZOLE
CAS Number: 102625-70-7
Current Spons
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Successful cardiopulmonary resuscitation (CPR) and target temperature management 18 years of age • planned treatment with erythromycin, paracetamol, pantoprazole Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: • Increased inflammatory biomarkers at admission (C-reactive protein>5mg/dL), if available • Expected life expectancy <3 days • Patients with esophageal temperature <34.0°C at admission • Known liver dysfunction (i.e. liver cirrhosis, history of significant liver disorders) • Chronic kidney failure • Intake of known inducers or inhibitors of CYP2C19 or CYP3A4 • Allergies of intolerances against any of the trial related substances • Prior erythromycin, pantoprazole or paracetamol treatment within 24 hours • Treatment with ciclosporin, tacrolimus, sirolimus, indinavir, ritonavir, saquinavir, or other drugs deemed relevant by the treating physician • Pregnancy or breastfeeding • Erythromycin: ongoing rhythm disturbances, such as ventricular tachycardias or ventricular fibrilliation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare the half-life of pantoprazole and erythromycin during cooling and after rewarming • To compare the maximum concentration (Cmax) of paracetamol during cooling and after rewarming ;Secondary Objective: • To correlate hepatic biomarkers and markers of systemic inflammation with the pharmacokinetics of both drugs • To measure the pharmacokinetics of paracetamol to assess gastric dysfunction and the impact of erythromycin on its resorption • To analyze the pharmacokinetics of erythromycin and pantoprazole;Primary end point(s): There are three main analysis planned within the trial: Half-life of pantoprazole during target temperature management and after rewarming Half-life of erythromycin during target temperature management and after rewarming Maximum Concentration of Paracetamol ;Timepoint(s) of evaluation of this end point: Pharmacokinetics will be evaluated as soon as target temperature is reached. For erythromycin: baseline, 15 minutes, 1h, 4h, 8h and 12h after intake For pantoprazole: baseline, 15 minutes, 1h, 4h, 8h, 24h after intake For paracetamol: baseline, 15 minutes, 30 minutes, 45 minutes, 1h, 2h, 4h hours after intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetics including Cmax, Tmax, AUC (0-T and 0-infinity), T1/2 Correlation with inflammatory biomarkers Correlation with hepatic biomarkers Analysis of genotypes Correlation with disease scores and mortality;Timepoint(s) of evaluation of this end point: Pharmacokinetics: For erythromycin: baseline, 15 minutes, 1h, 4h, 8h and 12h after intake For pantoprazole: baseline, 15 minutes, 1h, 4h, 8h, 24h after intake For paracetamol: baseline, 15 min, 30 min, 45 min, 60min, 2h and 3h after intake Biomarkers: Baseline, 24 hours, 48 hours Disease Scores: Baseline Mortality: Day 28/90 | — |
Countries
Austria
Contacts
Public ContactDepartment of Emergency Medicine
Medical University of Vienna
Outcome results
None listed