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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
Blood samples at T0, T0.5, T1, T2, T4, T6
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Identification of the pharmacokinetic parameters: AUC
Area under the curve (AUC)
Time frame: 8 hours (= during 1 dosing interval at steady state)
Identification of the pharmacokinetic parameters: Cmax
Peak plasma concentration after administration of paracetamol (Cmax)
Time frame: 8 hours (= during 1 dosing interval at steady state)
Identification of the pharmacokinetic parameters: Tmax
The time at which the Cmax is observed (Tmax) of paracetamol
Time frame: 8 hours (= during 1 dosing interval at steady state)
Variability in plasma exposure: Vd
Volume of distribution (Vd)
Time frame: 8 hours (= during 1 dosing interval at steady state)
Variability in plasma exposure: t1/2
Elimination half-life (t1/2)
Time frame: 8 hours (= during 1 dosing interval at steady state)
Variability in plasma exposure: Cl
Clearance (Cl)
Time frame: 8 hours (= during 1 dosing interval at steady state)
The association between the AUC (area under the curve) of paracetamol and patient related factors.
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.
Time frame: 8 hours (= during 1 dosing interval at steady state)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The association between the AUC (area under the curve) of paracetamol and pain scores.
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.
Time frame: 8 hours (= during 1 dosing interval at steady state)
Correlation between immuno assay method and the Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to determine paracetamol concentrations in serum
Correlation between two different assays will be determined through Bland Altman statistics.
Time frame: 8 hours (= during 1 dosing interval at steady state)