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GHB Poisoning and Poisoning Induced by Others

O

Odd Martin Vallersnes

Status

Completed

Conditions

Drug Toxicity

Study type

Observational

Funder types

Other

Identifiers

NCT03651778
2017/1880/REK

Details and patient eligibility

About

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.

Full description

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.

Enrollment

250 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

250 participants in 3 patient groups

Suspected spiked drink exposure, no assault
Suspected spiked drink exposure, sexual assault
Suspected GHB exposure

Trial contacts and locations

1

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Central trial contact

Vivian Dalaker, MD; Odd Martin Vallersnes, PhD, MD

Data sourced from clinicaltrials.gov

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