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GHB Poisoning and Poisoning Induced by Others

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ClinicalTrials.gov Identifier: NCT03651778
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
Lovisenberg Diakonale Hospital
Diakonhjemmet Hospital
Oslo University Hospital
University of Oslo
Oslo Accident and Emergency Outpatient Clinic
Information provided by (Responsible Party):
Odd Martin Vallersnes, University of Oslo

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.


Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Poisoning




Primary Outcome Measures :
  1. Proportion of patients with confirmed GHB poisoning in blood or oral fluid samples, and what other drugs were detected. [ Time Frame: 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. ]
    Blood and oral fluid samples will be analyzed looking for GHB and the most commonly used recreational drugs (including ethanol).

  2. Clinical factors at presentation predicting the necessity of hospital admission. [ Time Frame: 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. ]
    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.

  3. Recreational drugs (including ethanol) in blood and urine samples. [ Time Frame: Blood and urine samples will be collected at presentation to emergency health services, if within 48 hours of the suspected ingestion. ]
    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.


Biospecimen Retention:   Samples Without DNA
Blood, urine, oral fluid.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651778


Contacts
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Contact: Odd Martin Vallersnes, PhD, MD +4793082583 o.m.vallersnes@medisin.uio.no
Contact: Vivian Dalaker, MD +4793636675 vivian.dalaker@medisin.uio.no

Locations
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Norway
University of Oslo, Institute of Health and Society Recruiting
Oslo, Norway, Postboks 1130 Blindern 0318
Contact: Odd Martin Vallersnes, PhD, MD    +4793082583    o.m.vallersnes@medisin.uio.no   
Contact: Vivian Dalaker, MD    +4793636675    vivian.dalaker@medisin.uio.no   
Sponsors and Collaborators
Odd Martin Vallersnes
Lovisenberg Diakonale Hospital
Diakonhjemmet Hospital
Oslo University Hospital
University of Oslo
Oslo Accident and Emergency Outpatient Clinic

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Responsible Party: Odd Martin Vallersnes, Associate professor, University of Oslo
ClinicalTrials.gov Identifier: NCT03651778     History of Changes
Other Study ID Numbers: 2017/1880/REK
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Odd Martin Vallersnes, University of Oslo:
GHB
gamma-Hydroxybutyric acid
Substances of abuse
Poisoning induced by others
Recreational drugs
Poisoning
Intoxication

Additional relevant MeSH terms:
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Poisoning
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders