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

NCT01981213 | Unknown

• 1 other identifier: HIH-2011-17
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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. 1.An age-appropriate background population (approximately 200 patients)
2. 2.Paediatric patients that have been admitted to Rigshospitalet, due to severe hepatic injury (approximately 50 patients)
3. 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Expression of CYP 1A2 in a pediatric population

  2 years

• Characteristics, social behaviour, trends and risk factors

  2 years

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric Department, children/adolescents who have tried to commit suicide with acetaminophen (8-18 years-old)

You may qualify if:

• years-old, who tried to commit suicide with acetaminophen.
• Children are only included if they have answered all our standard questions.

You may not qualify if:

• Children with known liver disease prior to the suicide attempt.
• 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.

Sponsors & Collaborators

• Hillerod Hospital, Denmark: lead

Study Sites (1)

Nordsjællands Hospital

Hillerød, 3400, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The initial and maximum levels of the biochemical parameters will be registered from the electronic biochemistry files of each patient: GLU, basic phosphatase (BP), INR, ALT, and AST.

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Rikke L. Hedeland, MD

CONTACT

004548294356; rikke.hedeland@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 11, 2013
• Study Start: January 1, 2005
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 11, 2013

Record last verified: 2013-11

Locations

DK (1)