Reliability of the *on-site test* for gamma-hydroxybutyric acid (GHB) and the clinical relevance of this test: On-site DrugCheck® GHB Single Test * Express Diagnostics®
Withdrawn
- Conditions
- Diagnosis intake GHBidentification intake GHB.10071947
- Registration Number
- NL-OMON42350
- Lead Sponsor
- Onze Lieve Vrouwe Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 910
Inclusion Criteria
Patients with age 18-45 year with reduced consciousness GCS* 8
Patients with age 18-45 year without reduced consciousness who declare to have taken in GHB.
Exclusion Criteria
Age < 18 or > 45 year
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Determining the sensitivity and specificity of the on-site GHB test by<br /><br>comparing the results with the HPLC-MS/MS results.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Cinical relevance is determined based on a questionnaire filled in by the<br /><br>doctor, containing questions about the influence of the results of the test<br /><br>regarding the treatment.<br /><br>2. Alcohol promillages are measured in blood to rule out possible interference<br /><br>of alcohol on the test.<br /><br>3. Urine samples with a fals-postive on-site testresults are subjected to a<br /><br>urine toxscreen to determine interference with other drugs of abuse.<br /><br>4. The sensitivity and specificity of an immunoassaytechnique for the<br /><br>measurement of GHB-concentrations in urine will be investigated.</p><br>