Drug ToxicityNCT03651778
GHB Poisoning and Poisoning Induced by Others
An observational study of Drug Toxicity, run by Odd Martin Vallersnes at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Drug Toxicity
- How many people
- 250 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2018to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- patients under 16 years of age
Trial locations and contacts
1 site in 1 country.
Norway1 site
University of Oslo, Institute of Health and Society
Oslo, Oslo, Postboks 1130 Blindern 0318
About this study
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
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.
Read the 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.
- Conditions
- Drug Toxicity
- Keywords
- GHB, gamma-Hydroxybutyric acid, Substances of abuse, Poisoning induced by others, Recreational drugs, Poisoning, Intoxication
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suspected spiked drink exposure, no assault | Not described | |
| Suspected spiked drink exposure, sexual assault | Not described | |
| Suspected GHB exposure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Blood and urine samples will be collected at presentation to emergency health services, if within 48 hours of the suspected ingestion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Sep 2018
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odd Martin Vallersnes
- Sponsor type
- University, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital, Diakonhjemmet Hospital, Oslo University Hospital, University of Oslo, Oslo Accident and Emergency Outpatient Clinic
- Responsible party
- Sponsor-investigator, Odd Martin Vallersnes, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651778
- Sponsor's protocol ID
- 2017/1880/REK
- Status last verified
- Nov 2023
- First submitted
- 22 Aug 2018
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03651778
- Acronym / sponsor ID
- 2017/1880/REK
- Conditions
- Drug Toxicity
- Keywords
- GHB, gamma-Hydroxybutyric acid, Substances of abuse, Poisoning induced by others, Recreational drugs, Poisoning, Intoxication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Odd Martin VallersnesUniversity, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital, Diakonhjemmet Hospital, Oslo University Hospital, University of Oslo, Oslo Accident and Emergency Outpatient Clinic
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suspected spiked drink exposure, no assault | – | – |
| Suspected spiked drink exposure, sexual assault | – | – |
| Suspected GHB exposure | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- patients under 16 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
Related trials for Drug Toxicity
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
Not yet recruiting
Feasibility Study of Huangqi Yangyuan Formula for Capecitabine-Induced Adverse Reactions in Advanced Colorectal Cancer
Advanced Colorectal Cancer, Capecitabine-Related Adverse Reaction
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Active, not recruitingPhase 2
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
Melanoma Stage III, Melanoma Stage IV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Toxicity, run by Odd Martin Vallersnes at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.