GHB Poisoning and Poisoning Induced by Others

NCT03651778 | Completed

• 1 other identifier: 2017/1880/REK
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Toxicity

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Proportion of patients with confirmed GHB poisoning in blood or oral fluid samples, and what other drugs were detected.

  Blood and oral fluid samples will be analyzed looking for GHB and the most commonly used recreational drugs (including ethanol).

  Blood or oral fluid samples will be collected as soon as possible after presentation to the collaborating emergency health services, at the latest within 12 hours of presentation.

• Clinical factors at presentation predicting the necessity of hospital admission.

  We will do a multiple logistic regression analysis to identify factors associated with necessity of hospital admission. If during the clinical course of the poisoning episode the patient was intubated, had a GCS below 7, an arrhythmia requiring intervention, was admitted to an intensive care intake, or kept in hospital emergency department for more than 12 hours, the patient will be deemed as needing hospital admission as opposed to treatment in an emergency outpatient setting.

  Clinical factors will be assessed at the initial presentation to emergency health services. Criteria for necessity of hospital admission will be assessed at 12 hours after presentation to hospital emergency department.

• Recreational drugs (including ethanol) in blood and urine samples.

  Blood and urine samples will be analyzed, looking for the most commonly used recreational drugs and for the drugs most often used in poisoning inflicted by others.

  Blood and urine samples will be collected at presentation to emergency health services, if within 48 hours of the suspected ingestion.

Study Arms (3)

Suspected spiked drink exposure, no assault

Suspected spiked drink exposure, sexual assault

Suspected GHB exposure

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to Oslo Accident and Emergency Outpatient Clinik (Oslo Legevakt) or Oslo hospitals with clinically suspected GHB poisoning. Patients presenting to Oslo Accident and Emergency Outpatient Clinic (Oslo Legevakt) with suspected substance poisoning induced by others within the last 48 hours.

You may qualify if:

• 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.

You may not qualify if:

• patients under 16 years of age

Sponsors & Collaborators

• Odd Martin Vallersnes: lead
• Lovisenberg Diakonale Hospital: collaborator
• Diakonhjemmet Hospital: collaborator
• Oslo University Hospital: collaborator
• University of Oslo: collaborator
• Oslo Accident and Emergency Outpatient Clinic: collaborator

Study Sites (1)

University of Oslo, Institute of Health and Society

Oslo, Oslo County, Postboks 1130 Blindern 0318, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine, oral fluid.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Poisoning

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 29, 2018
• Study Start: September 1, 2018
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: December 11, 2024

Record last verified: 2023-11

Locations

NO (1)