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

NCT ID: NCT01981213

Last Updated: 2013-11-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2015-08-31

Brief 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.

Conditions

Hepatic Injury

Keywords

Acetaminophen; Suicide; Attempts; Early Predictors of Hepatic Injury; Childhood Suicidal Behaviour

Study Design

• Observational Model Type: CASE_ONLY

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hillerod Hospital, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Rikke Hedeland

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nordsjællands Hospital

Hillerød, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Rikke L. Hedeland, MD

Role: CONTACT

Phone: 004548294356

Email: rikke.hedeland@regionh.dk

Facility Contacts

Rikke L. Hedeland, MD

Role: primary

Other Identifiers

HIH-2011-17

Identifier Type: -

Identifier Source: org_study_id