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Completed

NCT Number: NCT03617471

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

About this study

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:

  • The variability in plasma exposure: volume of distribution (Vd), clearance (Cl) and elimination half-life (t1/2)
  • The association between the PK parameters and pathophysiological factors
  • The correlation between PK parameters and clinical parameters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venopuncture for PK profiling

Procedure

Blood samples at T0, T0.5, T1, T2, T4, T6

Other names: Blood sampling for paracetamol dosage

Primary outcomes

  1. Identification of the pharmacokinetic parameters: AUC

    Time frame: 8 hours (= during 1 dosing interval at steady state)

    Area under the curve (AUC)

  2. Identification of the pharmacokinetic parameters: Cmax

    Time frame: 8 hours (= during 1 dosing interval at steady state)

    Peak plasma concentration after administration of paracetamol (Cmax)

  3. Identification of the pharmacokinetic parameters: Tmax

    Time frame: 8 hours (= during 1 dosing interval at steady state)

    The time at which the Cmax is observed (Tmax) of paracetamol

Secondary outcomes

  1. Variability in plasma exposure: Vd

    Time frame: 8 hours (= during 1 dosing interval at steady state)

    Volume of distribution (Vd)

  2. Variability in plasma exposure: t1/2

    Time frame: 8 hours (= during 1 dosing interval at steady state)

    Elimination half-life (t1/2)

  3. Variability in plasma exposure: Cl

    Time frame: 8 hours (= during 1 dosing interval at steady state)

    Clearance (Cl)

  4. The association between the AUC (area under the curve) of paracetamol and patient related factors.

    Time frame: 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.

  5. The association between the AUC (area under the curve) of paracetamol and pain scores.

    Time frame: 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.

  6. Correlation between immuno assay method and the Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to determine paracetamol concentrations in serum

    Time frame: 8 hours (= during 1 dosing interval at steady state)

    Correlation between two different assays will be determined through Bland Altman statistics.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2020
First posted
Aug 6, 2018
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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