The primary objective is to develop a proof-of-concept analytical method to detect and identify volatile organic compounds linked to paracetamol in exhaled air. The secondary objective is to study the association between concentrations of…
ID
Source
Brief title
Condition
- Exposures, chemical injuries and poisoning
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is a difference in the intensity of GC-MS variables (M/Z
ratio's at a specific retention time) between time points before and after
paracetamol intake, determined via non-parametric univariate paired tests
(Wilcoxon signed rank).
Secondary outcome
The secondary endpoint is the association between concentrations of paracetamol
in the saliva and the obtained multivariate models and retaining univariate ion
fragments via ANCOVA.
Background summary
Paracetamol is used for pain or fever management. Overdose with paracetamol
occurs frequently and causes significant liver injury, potentially resulting in
fatal liver failure. Fast detection of paracetamol intake can support a
tentative clinical diagnosis of paracetamol overdose. Exhaled air is an
exciting matrix since it can be collected quickly. Over the last couple of
decades, exhaled air has been identified as a possible matrix for detecting
xenobiotic substances, including amphetamines, tetrahydrocannabinol, propofol,
methadone, and valproic acid. We hypothesize that a similar route of excretion
exists for paracetamol.This excretion route would make exhaled air a potential
matrix for non-invasive paracetamol sampling instead of the current golden
standard of invasive blood sampling. This could lead to feature developments in
non-invasive paracetamol screenings at the emergency care department. Here, we
want to develop an analytical method to determine the presence of paracetamol
and related metabolites in exhaled air via GC-MS.
Study objective
The primary objective is to develop a proof-of-concept analytical method to
detect and identify volatile organic compounds linked to paracetamol in exhaled
air. The secondary objective is to study the association between concentrations
of paracetamol in the saliva and quantative outcomes of identified compounds in
exhaled air.
Study design
Openlabel, single centre, cross-over study
Intervention
Volunteers will receive two 500 mg paracetamol tablets orally in the fasting
state. If early data analyses are successful, the volunteers will receive one
500 mg paracetamol tablet in the fasting state, separated by a wash-out period
of a minimum of 1 week. During both days, 3 saliva samples and 10 breath
samples are taken.
Study burden and risks
Each subject will have 2 hospital visits separated by a wash-out period of at
least 1 week. The subject will orally take 2 tablets of 500 mg paracetamol on
the first hospital visit and 1 tablet of 500 mg on the second hospital visit.
Dietary restrictions are in place 8 hours before administration and during the
4-hour sampling period. Breath samples will be withdrawn at 10 time points over
4,5 hours. Saliva samples will be withdrawn at 3 time points over 4,5 hours.
The risk associated with the treatment are limited since paracetamol does not
have common side effects.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Age between >= 18 and <= 65 years.
The volunteer is able and willing to give written informed consent.
Have a BMI between 18,5 and 30 kg/m2
Able and willing to swallow tablets
Willing to follow the dietary restrictions
Exclusion criteria
Known substance abuse, psychotic disorders, and/or other diseases expected to
interfere with the study or the patient*s safety.
A body weight <= 50 kg.
When unable to exhale the specified volume of air into the collection device at
the time of inclusion.
When unable to collect saliva
Smoking tobacco products 1 week before the start of the study intervention
Known pregnancy or breast feeding
Known liver failure (ALAT, ASAT above 3x upper normal limit) or liver disease
related coagulation deficiencies (INR > 1.0)
In case of being in a dehydrated state
In case of chronic undereating
Administration of paracetamol within 1 week before start of the study
intervention
Known allergy to paracetamol
Alcohol intake 24 hours before paracetamol administration
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83513.018.22 |