Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward
- Conditions
- Pain
- Interventions
- Procedure: Venopuncture for PK profiling
- Registration Number
- NCT03617471
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
The goal of this exploratory study is the characterization of the pharmacokinetic (PK) profile of paracetamol in older patients and the specific PK (pharmacokinetic) variables associated with plasma exposure in this population.
- Detailed Description
The goal of this exploratory study is the characterization of the pharmacokinetic profile of paracetamol in older patients and the specific PK variables associated with plasma exposure in this population. The primary endpoint is the identification of the pharmacokinetic parameters: area under the curve (AUC), peak plasma concentration after administration of paracetamol (Cmax) and the time at which the Cmax is observed (Tmax) of paracetamol. The secondary endpoint consists of 3 sub-endpoints:
1. The variability in plasma exposure: volume of distribution (Vd), clearance (Cl) and elimination half-life (t1/2)
2. The association between the PK parameters and pathophysiological factors
3. The correlation between PK parameters and clinical parameters.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- a minimum age of 80 years
- admission to the acute geriatrics ward
- oral intake of paracetamol 1000 milligram (mg) in tablet form tid
- a steady state situation (defined as at least 4 consecutive intakes of paracetamol before sampling)
- palliative care setting with downgrading of care
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paracetamol oral tablets 1g tid Venopuncture for PK profiling Patients received paracetamol one gram three times daily. Venopuncture for PK profiling Paracetamol oral granules 1g tid Venopuncture for PK profiling Patients received paracetamol one gram three times daily. Venopuncture for PK profiling
- Primary Outcome Measures
Name Time Method Identification of the pharmacokinetic parameters: AUC 8 hours (= during 1 dosing interval at steady state) Area under the curve (AUC)
Identification of the pharmacokinetic parameters: Cmax 8 hours (= during 1 dosing interval at steady state) Peak plasma concentration after administration of paracetamol (Cmax)
Identification of the pharmacokinetic parameters: Tmax 8 hours (= during 1 dosing interval at steady state) The time at which the Cmax is observed (Tmax) of paracetamol
- Secondary Outcome Measures
Name Time Method Variability in plasma exposure: t1/2 8 hours (= during 1 dosing interval at steady state) Elimination half-life (t1/2)
Variability in plasma exposure: Vd 8 hours (= during 1 dosing interval at steady state) Volume of distribution (Vd)
The association between the AUC (area under the curve) of paracetamol and patient related factors. 8 hours (= during 1 dosing interval at steady state) Multivariate analysis will be performed with AUC (area under the curve) as outcome. This will allow to identify variables influencing AUC of paracetamol. Patient related factors include amongst others age, weight, albumin, bilirubin, serum creatinin and co medication.
Correlation between immuno assay method and the Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to determine paracetamol concentrations in serum 8 hours (= during 1 dosing interval at steady state) Correlation between two different assays will be determined through Bland Altman statistics.
The association between the AUC (area under the curve) of paracetamol and pain scores. 8 hours (= during 1 dosing interval at steady state) Pain scores will be based on the Numeric Rating Scale with a score of 0 indicating no pain and a score of 10 indicating worst imaginable pain.
Variability in plasma exposure: Cl 8 hours (= during 1 dosing interval at steady state) Clearance (Cl)
Trial Locations
- Locations (1)
Universitaire Ziekenhuizen Leuven
🇧🇪Leuven, Belgium