Determining the sensitivity and specificity of the on-site GHB test.
ID
Source
Brief title
Condition
- Exposures, chemical injuries and poisoning
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determining the sensitivity and specificity of the on-site GHB test by
comparing the results with the HPLC-MS/MS results.
Secondary outcome
1. Cinical relevance is determined based on a questionnaire filled in by the
doctor, containing questions about the influence of the results of the test
regarding the treatment.
2. Alcohol promillages are measured in blood to rule out possible interference
of alcohol on the test.
3. Urine samples with a fals-postive on-site testresults are subjected to a
urine toxscreen to determine interference with other drugs of abuse.
4. The sensitivity and specificity of an immunoassaytechnique for the
measurement of GHB-concentrations in urine will be investigated.
Background summary
Currently it's not possible to carry out a quick measurement of the
concentration GHB in the urine or blood when a patient presents with a reduced
consciousness at the emergency department. By the time analysis of GHB in urine
or blood at the clinical pharmaceutical laboratory is completed, the patient
has awoken out of the GHB-induced coma. Therefore no added value is stated for
the analysis in the clinical pharmaceutical laboratory in terms of diagnosis
and treatment.
In some situations the quick measurement of GHB concentrations is very useful
to figure out possible intake of GHB. For example for patients with trauma or
coma due to a mixed intoxication the test might be useful to determine the
right treatment. Plausible result might be a reduce in the amount of CTs of the
cerebrum and other added diagnostics.
Study objective
Determining the sensitivity and specificity of the on-site GHB test.
Study design
Urine and blood is conform standard care taken from patients with a reduced
consciousness or a possible GHB intoxication at the emergency department. An
extra 5 ml blood is taken for this study. Patients who claim to have taken in
GHB without reduced consiousness are asked to give urine and blood; this is not
standard practice. A short questionnaire is filled in by the doctor, containing
questions about the influence of the results of the test regarding the
treatment. GHB-concentrations are measured in the urine with the on-site GHB
test and a validated HPLC-MS/MS method to determine the sensitivity and
specificity of the on-site test. Alcohol promillages are measured in blood to
rule out possible interference of alcohol on the test. Urine samples with a
fals-postive on-site testresults are subjected to a urine toxscreen to
determine interference with other drugs of abuse. Also, the sensitivity and
specificity of an immunoassaytechnique for the measurement of
GHB-concentrations in urine will be investigated.
Study burden and risks
Risk associated with participation is low. Normally, blood and urine is taken
in most situations of patients with reduces consciousness.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
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
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 | NL55233.100.15 |