GHB Poisoning and Poisoning Induced by Others

Laboratory Analysis of Toxic Agents in Suspected GHB Poisoning, Clinical Course and Predictors of Hospitalization in GHB Poisoning, and Laboratory Analysis of Toxic Agents in Poisoning Induced by Others

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Drug Toxicity

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

• Study Contact: Name: Odd Martin Vallersnes, PhD, MD; Phone Number: +4793082583; Email: o.m.vallersnes@medisin.uio.no
• Study Contact Backup: Name: Vivian Dalaker, MD; Phone Number: +4793636675; Email: vivian.dalaker@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, Postboks 1130 Blindern 0318
    • University of Oslo, Institute of Health and Society

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Suspected spiked drink exposure, no assault
Suspected spiked drink exposure, sexual assault
Suspected GHB exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Odd Martin Vallersnes
• Collaborators: University of Oslo; Oslo University Hospital; Diakonhjemmet Hospital; Lovisenberg Diakonale Hospital; Oslo Accident and Emergency Outpatient Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Recreational drugs; Intoxication; GHB; Poisoning; gamma-Hydroxybutyric acid; Substances of abuse; Poisoning induced by others
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 2017/1880/REK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No