Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward

Pain Clinical Trial

Official title:

Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03617471
• Other study ID #: S58396 - mp05485
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: April 2020

Study information

• Verified date: November 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2020
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Venopuncture for PK profiling
Blood samples at T0, T0.5, T1, T2, T4, T6

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of the pharmacokinetic parameters: AUC	Area under the curve (AUC)	8 hours (= during 1 dosing interval at steady state)
Primary	Identification of the pharmacokinetic parameters: Cmax	Peak plasma concentration after administration of paracetamol (Cmax)	8 hours (= during 1 dosing interval at steady state)
Primary	Identification of the pharmacokinetic parameters: Tmax	The time at which the Cmax is observed (Tmax) of paracetamol	8 hours (= during 1 dosing interval at steady state)
Secondary	Variability in plasma exposure: Vd	Volume of distribution (Vd)	8 hours (= during 1 dosing interval at steady state)
Secondary	Variability in plasma exposure: t1/2	Elimination half-life (t1/2)	8 hours (= during 1 dosing interval at steady state)
Secondary	Variability in plasma exposure: Cl	Clearance (Cl)	8 hours (= during 1 dosing interval at steady state)
Secondary	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.	8 hours (= during 1 dosing interval at steady state)
Secondary	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.	8 hours (= during 1 dosing interval at steady state)
Secondary	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.	8 hours (= during 1 dosing interval at steady state)