Hepatic InjuryNCT01981213
Attempted Suicide With Acetaminophen Among 8-18 Year-old Children / Adolescents in Denmark
An observational study of Hepatic Injury, run by Hillerod Hospital, Denmark at 1 site in Denmark.
Trial summary
A: Early predictors of hepatic injury after suicide attempt with acetaminophen: To explore the following in a pediatric population with acetaminophen overdose due to suicide attempt: 1) the prevalence of episodes of pre- and in-hospital vomiting and the relationship between the total number of vomiting episodes and… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Hepatic Injury
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2005to Aug 2015
- How long will I take part?
- 5 Days
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric Department, children/adolescents who have tried to commit suicide with acetaminophen (8-18 years-old)
Who may be able to join
- 8-18 years-old, who tried to commit suicide with acetaminophen.
- Children are only included if they have answered all our standard questions.
Who cannot join
- Children with known liver disease prior to the suicide attempt.
- If a child have several suicide attempts during the inclusion-period, only the 1st will be included.
- Suicide attempts with other agents than acetaminophen.
- Children taking medication that enhance the induction of the cytochrome P450 system, increase the production of toxic metabolites, and aggravate the hepatic injury, such as ethanol, rifampin, isoniazid, barbiturates, and carbamazepine, will be excluded.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Nordsjællands Hospital
Hillerød, 3400
Rikke L. Hedeland, MD
Rikke L. Hedeland, MD
About this study
Official title: Attempted Suicide With Acetaminophen Among 8-18 Year-old Children / Adolescents
A: Early predictors of hepatic injury after suicide attempt with acetaminophen:
To explore the following in a pediatric population with acetaminophen overdose due to suicide attempt: 1) the prevalence of episodes of pre- and in-hospital vomiting and the relationship between the total number of vomiting episodes and hepatic injury, 2) the relevance of the early initiation of N-acetylcysteine (NAC) treatment to hepatic injury, and 3) the presence/absence of illness prior to the suicide attempt and hepatic injury.
Read more
B: Characteristics, social behaviour, trends and risk factors:
- To explore the relationship between children admitted to a paediatric department as a result of suicide attempts with acetaminophen and their parents and friends. 2. To determine the extent to which the children had attempted to speak to their parents or other adults about their problems before their suicide attempts. 3. To determine the prevalence of self-mutilation among children with suicidal behaviour. 4. To examine the reasons for these suicide attempts.
C: Establishment of the expression of cytochrome P450 in a pediatric including the age-adjusted activities.
Urine samples will be analyzed using an HPLC tandem mass spectrometric method, which we have already established in our lab.
There will be categorized three groups for comparison:
- An age-appropriate background population (approximately 200 patients)
- Paediatric patients that have been admitted to Rigshospitalet, due to severe hepatic injury (approximately 50 patients)
- Other pediatric patients admitted to their local hospital because of acetaminophen poisoning (approximately 200 patients) A control urine sample will be analyzed three months after the suicide attempt.
- Conditions
- Hepatic Injury
- Keywords
- Acetaminophen, Suicide, Attempts, Early Predictors of Hepatic Injury, Childhood Suicidal Behaviour
- Medical subject headings
- Suicide
What is being measured
The primary outcome is the main question the study is designed to answer.
Early predictors of hepatic injury
- To identify early clinical and biochemical predictors of hepatoxicity in children and adolescents after the ingestion of a single acetaminophen overdose as a part of a suicide attempt e.g. pre-hospital vomiting, in-hospital vomiting, stomach pains, latency time before NAC treatment, illness prior to the suicide attempt. The initial and maximum levels of the following biochemical parameters are registered from the electronic biochemistry files of each patient: gluthathione (GLU), basic phosphatase (BP), INR, ALT, AST, and s-acetaminophen.
Measured: 2 years
Secondary outcomes (2)
Expression of CYP 1A2 in a pediatric population
The expression of cytochrome P450 in a pediatric population including the age-adjusted activities.
Urine samples will be analyzed using an HPLC tandem mass spectrometric method, which we have already established in our lab.
There will be categorized three groups for comparison:
An age-appropriate background population (approximately 200 patients) Paediatric patients that have been admitted to Rigshospitalet, due to severe hepatic injury (approximately 50 patients) Other pediatric patients admitted to their local hospital because of acetaminophen poisoning (approximately 200 patients) A control urine sample will be analyzed three months after the suicide attempt.
Measured: 2 years
Characteristics, social behaviour, trends and risk factors
1)The relationship children with suicidal behaviour have with their parents and friends. 2)The prevalence of self-mutilation among children with suicidal behaviour. 3)The purposes and main reasons for suicide attempts among children/adolescents. 4) The extent to which these suicide attempts are planned. 5) The extent of acetaminophen intake.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJan 2005
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InjuryStudies 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
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Hillerod Hospital, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikke Hedeland, Hillerod Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981213
- Sponsor's protocol ID
- HIH-2011-17
- Status last verified
- Nov 2013
- First submitted
- 24 Oct 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attempted Suicide With Acetaminophen Among 8-18 Year-old Children / Adolescents
- ClinicalTrials.gov ID
- NCT01981213
- Acronym / sponsor ID
- HIH-2011-17
- Conditions
- Hepatic Injury
- Keywords
- Acetaminophen, Suicide, Attempts, Early Predictors of Hepatic Injury, Childhood Suicidal Behaviour
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 11 Nov 2013 (estimated)
- 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.
A: Early predictors of hepatic injury after suicide attempt with acetaminophen:
To explore the following in a pediatric population with acetaminophen overdose due to suicide attempt: 1) the prevalence of episodes of pre- and in-hospital vomiting and the relationship between the total number of vomiting episodes and hepatic injury, 2) the relevance of the early initiation of N-acetylcysteine (NAC) treatment to hepatic injury, and 3) the presence/absence of illness prior to the suicide attempt and hepatic injury.
B: Characteristics, social behaviour, trends and risk factors:
- To explore the relationship between children admitted to a paediatric department as a result of suicide attempts with acetaminophen and their parents and friends. 2. To determine the extent to which the children had attempted to speak to their parents or other adults about their problems before their suicide attempts. 3. To determine the prevalence of self-mutilation among children with suicidal behaviour. 4. To examine the reasons for these suicide attempts.
C: Establishment of the expression of cytochrome P450 in a pediatric including the age-adjusted activities.
Urine samples will be analyzed using an HPLC tandem mass spectrometric method, which we have already established in our lab.
There will be categorized three groups for comparison:
- An age-appropriate background population (approximately 200 patients)
- Paediatric patients that have been admitted to Rigshospitalet, due to severe hepatic injury (approximately 50 patients)
- Other pediatric patients admitted to their local hospital because of acetaminophen poisoning (approximately 200 patients) A control urine sample will be analyzed three months after the suicide attempt.
Study design
- Observational model
- Case only
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric Department, children/adolescents who have tried to commit suicide with acetaminophen (8-18 years-old)
Key inclusion criteria (2 listed)
- 8-18 years-old, who tried to commit suicide with acetaminophen.
- Children are only included if they have answered all our standard questions.
Key exclusion criteria (4 listed)
- Children with known liver disease prior to the suicide attempt.
- If a child have several suicide attempts during the inclusion-period, only the 1st will be included.
- Suicide attempts with other agents than acetaminophen.
- Children taking medication that enhance the induction of the cytochrome P450 system, increase the production of toxic metabolites, and aggravate the hepatic injury, such as ethanol, rifampin, isoniazid, barbiturates, and carbamazepine, will be excluded.
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
Early predictors of hepatic injury
Time frame: 2 years
1) To identify early clinical and biochemical predictors of hepatoxicity in children and adolescents after the ingestion of a single acetaminophen overdose as a part of a suicide attempt e.g. pre-hospital vomiting, in-hospital vomiting, stomach pains, latency time before NAC treatment, illness prior to the suicide attempt. The initial and maximum levels of the following biochemical parameters are registered from the electronic biochemistry files of each patient: gluthathione (GLU), basic phosphatase (BP), INR, ALT, AST, and s-acetaminophen.
2 secondary outcomes
Expression of CYP 1A2 in a pediatric population
Time frame: 2 years
Characteristics, social behaviour, trends and risk factors
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
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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.
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 Hepatic Injury, run by Hillerod Hospital, Denmark at 1 site in Denmark.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Nov 2013. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rikke L. Hedeland, MD (004548294356, rikke.hedeland@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early predictors of hepatic injury (time frame: 2 years). 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 Nov 2013.