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

NCT01692639 | Terminated

• 1 other identifier: 5313
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 10

Brief 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?

Conditions

Acetaminophen Overdose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years with acute paracetamol ingestion admitted in a group of 8 emergency departments of the region Alsace, France (Strasbourg Hautepierre and Nouvel Hôpital Civil, Haguenau, Saverne,Wissembourg, Colmar, Sélestat, Mulhouse) and with a single dose of paracetamol over 4 grams.

You may qualify if:

• Patients over 18 years
• Having taken a single dose of acetaminophen
• With a supposed ingested dose over 4 grams

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (10)

Centre Hospitalier Gérontologique

Bischwiller, 67241, France

Location

Service d'accueil des Urgences, Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur

Colmar, 68024, France

Location

Service d'Accueil des Urgences, Centre Hospitalier de Haguenau

Haguenau, 67500, France

Location

Service des Urgences, CH Emile Muller

Mulhouse, 68051, France

Location

Service des Urgences, Centre Hospitalier de Sélestat

Sélestat, 67606, France

Location

Service d'Accueil des Urgences, Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Service de Réanimation Médicale, Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Service de Réanimation Médicale, Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Service des Urgences, Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Service des Urgences, Centre Hospitalier Intercommunal de la Lauter

Wissembourg, 67160, France

Location

Study Officials

• Pascal BILBAULT, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 25, 2012
• Study Start: May 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

FR (10)