GHB Poisoning and Poisoning Induced by Others

NCT ID: NCT03651778

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2023-11-01

Brief Summary

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Patients with suspected GHB poisoning presenting to Oslo Accident and Emergency Outpatient Clinic (Oslo Legevakt) or a hospital in Oslo (Oslo University Hospital Ullevål, Diakonhjemmet, Lovisenberg) will be included. Oral fluid and blood tests will be analyzed for recreational drugs. Clinical course will be charted, as well as treatment in the ambulance, emergency outpatient clinic and hospital to find predictors for when hospitalization is required.

In the second part of the study the investigators will analyze urine and blood samples from patients presenting to the Oslo Accident and Emergency Outpatient Clinic (Oslo Legevakt) with suspected substance poisoning induced by others, for toxic agents.

Detailed Description

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Gammahydroxybutyrate (GHB) causes severe poisoning that requires emergency medical and hospital care. In addition, it is used as an anesthetic for planned sexual assault. Laboratory analyses will help assess whether today's clinical diagnostics of GHB poisoning are precise enough, possibly being a supplement to improve it. Can GHB poisoned patients be treated safely by emergency medical services or do these patients need hospitalization?

In case of substance poisoning induced by others, sampling could identify substances that are quickly excreted from the body. Today patients are referred to private laboratories the following day, delaying the diagnosis and missing short-term drugs.

Method: Prospective study. Oral fluid and blood samples will be collected from patients over 16 years of age where there is a clinical suspicion of GHB poisoning on arrival at Oslo Accident and Emergency Outpasient Clinic (Oslo Legevakt) or hospital (OUH Ullevål, Lovisenberg and Diakonhjemmet). Blood and urine samples will be collected from patients over the age of 16 who present at the Oslo Accident and Emergency Outpasient clinic (Oslo Legevakt) with suspected substance poisoning induced by others. In both pasient groups the investigators will also register age, gender, clinically suspected toxic agents, vital signs, clinical features and treatment.

The aims of this study are to see if the clinical diagnosis of GHB poisoning is precise enough, and whether more patients can be handled at an emergency outpatient level. Furthermore, analysis of blood and urine samples from patients who suspect they have been poisoned by substances induced by others, will be done to identify toxic agents.

Conditions

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Drug Toxicity

Keywords

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GHB gamma-Hydroxybutyric acid Substances of abuse Poisoning induced by others Recreational drugs Poisoning Intoxication

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspected spiked drink exposure, no assault

No interventions assigned to this group

Suspected spiked drink exposure, sexual assault

No interventions assigned to this group

Suspected GHB exposure

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Clinically suspected GHB poisoning means patients

* who are comatose or have varying level of consciousness,
* where there is absence of signs of opioid poisoning or poisoning with other agents,
* where there is no effect of naloxone,
* where there is information from a patient or companion about the intake of GHB
* or where there is a finding of GHB in the patient's belongings.

Exclusion Criteria

* patients under 16 years of age
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lovisenberg Diakonale Hospital

OTHER

Sponsor Role collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Oslo Accident and Emergency Outpatient Clinic

UNKNOWN

Sponsor Role collaborator

Odd Martin Vallersnes

OTHER

Sponsor Role lead

Responsible Party

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Odd Martin Vallersnes

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Oslo, Institute of Health and Society

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

Other Identifiers

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2017/1880/REK

Identifier Type: -

Identifier Source: org_study_id