Attempted Suicide With Acetaminophen Among 8-18 Year-old Children / Adolescents in Denmark

Hepatic Injury Clinical Trial

Official title:

Attempted Suicide With Acetaminophen Among 8-18 Year-old Children / Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01981213
• Other study ID #: HIH-2011-17
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2013
• Last updated: November 5, 2013
• Start date: January 2005
• Est. completion date: August 2015

Study information

• Verified date: November 2013
• Source: Hillerod Hospital, Denmark
• Contact: Rikke L. Hedeland, MD
• Phone: 004548294356
• Email: rikke.hedeland[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Health and Medicines Authority
• Study type: Observational [Patient Registry]

Clinical 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 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:

1. 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:

1. An age-appropriate background population (approximately 200 patients)

2. Paediatric patients that have been admitted to Rigshospitalet, due to severe hepatic injury (approximately 50 patients)

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• 8-18 years-old, who tried to commit suicide with acetaminophen.

• Children are only included if they have answered all our standard questions.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Hepatic Injury
• Suicide, Attempted

Locations

Country	Name	City	State
Denmark	Nordsjællands Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Hillerod Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early predictors of hepatic injury	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 years	No
Secondary	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.	2 years	No
Secondary	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.	2 years	No