Acute Acetaminophen Ingestion: Does Repeated Acetaminophen Blood Test Have an Interest?

Acetaminophen Overdose Clinical Trial

Official title:

Acute Acetaminophen Ingestion: Does Repeated Acetaminophen Blood Test Have an Interest?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01692639
• Other study ID #: 5313
• Status: Terminated
• Phase: N/A
• First received: September 19, 2012
• Last updated: March 2, 2016
• Start date: May 2013
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France:France: Institutional Ethical Committee.France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial Summary

Acetaminophen is the first drug involved in voluntary drug poisoning. According to the studies conducted in the USA and in the United Kingdom, it is the first cause of acute liver failure, and this poisoning is responsible of 10 percent of liver transplants each year in these countries. Mortality is about 1/3 at the stage of acute liver failure. The main risk factors are malnutrition and chronic alcoholism. Ease of access to this toxic and highly correlated with factors predisposing socio-economic field are an important issue, including the speed and appropriateness of care are key factors both in terms of reducing morbidity mortality in socio-economic terms for the community.A nomogram defines a statistical threshold from which the blood concentration of paracetamol has a significant risk of liver toxicity. The blood paracetamol dosage practiced today at the 4th hour after ingestion of a toxic dose, but there is no consensus on whether or not to repeat this dosage during the treatment, as the first result is beyond the threshold or not.The administration of the antidote NAC (N-acetyl-cysteine) in proven cases of liver toxicity is also regulated by a protocol that can vary in different services.In the absence of clear guidelines, the question of the need for iterative dosages of paracetamol blood beyond the fourth hour post-ingestion if the initial paracetamol blood measurement is below the curve nomogram remains open.Is it possible to limit blood tests to a single assay paracétamolémie to H4 when it is below the curve, and thus enable the return home of the patient's somatic point of view (excluding psychiatric care when is voluntary drug intoxication), with consequences in terms of costs (hospital days) and duration of treatment?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years

• Having taken a single dose of acetaminophen

• With a supposed ingested dose over 4 grams

Exclusion Criteria:

• Patients treated with N-Acetyl

• Cysteine before their admissions in the participating units

• With repeted ingested doses

• Pregnant and nursing wifes

• Patients unable to give their consent to the study

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acetaminophen Overdose

Locations

Country	Name	City	State
France	Centre Hospitalier Gérontologique	Bischwiller
France	Service d'accueil des Urgences, Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur	Colmar
France	Service d'Accueil des Urgences, Centre Hospitalier de Haguenau	Haguenau
France	Service des Urgences, CH Emile Muller	Mulhouse
France	Service des Urgences, Centre Hospitalier de Sélestat	Selestat
France	Service d'Accueil des Urgences, Nouvel Hôpital Civil	Strasbourg
France	Service de Réanimation Médicale, Hôpital de Hautepierre	Strasbourg
France	Service de Réanimation Médicale, Nouvel Hôpital Civil	Strasbourg
France	Service des Urgences, Hôpital de Hautepierre	Strasbourg
France	Service des Urgences, Centre Hospitalier Intercommunal de la Lauter	Wissembourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France,