PharmacokineticsNCT05167591
Detection of Paracetamol Concentration in Patients Using Regular Medication- a Validation Study for a Novel Technique
A study testing Drug concentration measurement in people with Pharmacokinetics, run by Johanna Kujala.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Drug concentration measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 4 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Determination of Serum Paracetamol Concentration With an Electrochemical Measurement Tool From Blood and Saliva Samples in Patients Using Also Other Medication.
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.
Read the detailed description
Paracetamol concentration analysis is performed in 20 patients who will come to hospital for elective surgery. Inclusion criteria is a regular medication that continues over perioperative period.
Patients will be given standard premedication of paracetamol 1g perorally before surgery: this study does not affect standard surgical treatment.
Paracetamol concentration will be measured in venous plasma-, capillary blood-, and saliva samples before drug delivery and in recovery room after surgery using the novel electrochemical analysis tool and high-performance mass spectrometry analysis as a reference. If needed, confounding medication is identified with large toxicologic mass spectrometry screen (UPLC-QTOF).
- Conditions
- Pharmacokinetics
- Being tested
- Drug concentration measurement
- Keywords
- Electrochemical, Paracetamol, Saliva, Fingerprick, Capillary sample, Acetaminophen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug concentration measurementDiagnostic test
Measurement of paracetamol concentration in capillary, venous plasma and saliva samples after standard premedication with paracetamol
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Measurements of paracetamol concentration Receives: Diagnostic Test: Drug concentration measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
No outcome for patients
Comparison of paracetamol concentration (µmol/L) measurements in saliva-, plasma-, and capillary samples and between mass-spectrometry and electrochemical techniques.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Mar 2024 (estimated)
- Primary completion4 Mar 2024 (estimated)
- Study completion4 Mar 2024 (estimated)
Why it stopped: The design of the study is no longer relevant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johanna Kujala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johanna Kujala, Helsinki University Central Hospital
- Investigators
- Eija Kalso, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167591
- Sponsor's protocol ID
- FEPODPara2021-1
- Status last verified
- Mar 2024
- First submitted
- 26 Nov 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Serum Paracetamol Concentration With an Electrochemical Measurement Tool From Blood and Saliva Samples in Patients Using Also Other Medication.
- ClinicalTrials.gov ID
- NCT05167591
- Acronym / sponsor ID
- FEPODPara2021-1
- Conditions
- Pharmacokinetics
- Keywords
- Electrochemical, Paracetamol, Saliva, Fingerprick, Capillary sample, Acetaminophen
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The design of the study is no longer relevant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johanna KujalaUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 4 Mar 2024 (estimated)
- Study completion
- 4 Mar 2024 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Paracetamol concentration analysis is performed in 20 patients who will come to hospital for elective surgery. Inclusion criteria is a regular medication that continues over perioperative period.
Patients will be given standard premedication of paracetamol 1g perorally before surgery: this study does not affect standard surgical treatment.
Paracetamol concentration will be measured in venous plasma-, capillary blood-, and saliva samples before drug delivery and in recovery room after surgery using the novel electrochemical analysis tool and high-performance mass spectrometry analysis as a reference. If needed, confounding medication is identified with large toxicologic mass spectrometry screen (UPLC-QTOF).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Diagnostic Test: Drug concentration measurementMeasurements of paracetamol concentration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug concentration measurementMeasurement of paracetamol concentration in capillary, venous plasma and saliva samples after standard premedication with paracetamol | Diagnostic test | Study group |
Primary outcome
No outcome for patients
Time frame: 24 hours
Comparison of paracetamol concentration (µmol/L) measurements in saliva-, plasma-, and capillary samples and between mass-spectrometry and electrochemical techniques.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eija Kalso principal investigator
University of Helsinki
Questions about this trial
What is this clinical trial studying?
A study testing Drug concentration measurement in people with Pharmacokinetics, run by Johanna Kujala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No outcome for patients (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.