NCT05167591

Brief Summary

Paracetamol intoxication is common, and concentration measurements are performed regularly. This research group is developing a fast bedside electrochemical analysis tool for paracetamol concentration measurement. This study will find out how this novel method performs in patients using other, confounding medication in detecting paracetamol concentration in capillary blood, venous plasma and saliva samples.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2024

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
2.2 years until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

3 days

First QC Date

November 26, 2021

Last Update Submit

March 4, 2024

Conditions

Pharmacokinetics

Keywords

ElectrochemicalParacetamolSalivaFingerprickCapillary sampleAcetaminophen

Outcome Measures

Primary Outcomes (1)

  • No outcome for patients

    Comparison of paracetamol concentration (µmol/L) measurements in saliva-, plasma-, and capillary samples and between mass-spectrometry and electrochemical techniques.

    24 hours

Study Arms (1)

Study group

EXPERIMENTAL

Measurements of paracetamol concentration

Diagnostic Test: Drug concentration measurement

Interventions

Drug concentration measurementDIAGNOSTIC_TEST

Measurement of paracetamol concentration in capillary, venous plasma and saliva samples after standard premedication with paracetamol

Study group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent
  • Age 18-75 years
  • American society of anesthesiologist classification 2-4
  • planned elective surgery with standard premedication with paracetamol 1g po.
  • at least one regular medication ongoing perioperatively
  • eligibility for elective surgery
  • negative pregnancy test in fertile women

You may not qualify if:

  • American society of anesthesiologists classification 1
  • contraindication for use of paracetamol as standard premedication
  • pregnancy or lactation
  • less than 3 months from previous drug research
  • less than 3 months from previous blood donation
  • anticipated difficult puncture of veins
  • Body Mass Index lower than 18.5 or higher than 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Eija Kalso

    University of Helsinki

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

November 26, 2021

First Posted

December 22, 2021

Study Start

March 1, 2024

Primary Completion

March 4, 2024

Study Completion

March 4, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share