Clinical trial NCT03617471: Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward
Official title: Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2018-08-06
Enrollment: 36
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* palliative care setting with downgrading of care

Primary outcomes:
measure: Identification of the pharmacokinetic parameters: AUC
timeFrame: 8 hours (= during 1 dosing interval at steady state)
measure: Identification of the pharmacokinetic parameters: Cmax
timeFrame: 8 hours (= during 1 dosing interval at steady state)
measure: Identification of the pharmacokinetic parameters: Tmax
timeFrame: 8 hours (= during 1 dosing interval at steady state)
Secondary outcomes:
measure: Variability in plasma exposure: Vd
timeFrame: 8 hours (= during 1 dosing interval at steady state)
measure: Variability in plasma exposure: t1/2
timeFrame: 8 hours (= during 1 dosing interval at steady state)
measure: Variability in plasma exposure: Cl
timeFrame: 8 hours (= during 1 dosing interval at steady state)
measure: The association between the AUC (area under the curve) of paracetamol and patient related factors.
timeFrame: 8 hours (= during 1 dosing interval at steady state)
measure: The association between the AUC (area under the curve) of paracetamol and pain scores.
timeFrame: 8 hours (= during 1 dosing interval at steady state)
measure: Correlation between immuno assay method and the Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to determine paracetamol concentrations in serum
timeFrame: 8 hours (= during 1 dosing interval at steady state)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Isabel Spriet, PharmD PhD
role: PRINCIPAL_INVESTIGATOR
References: