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

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?

Study Overview

• Status: Terminated
• Conditions: Acetaminophen Overdose

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• France
  • Bischwiller, France, 67241
    • Centre Hospitalier Gérontologique
  • Colmar, France, 68024
    • Service d'accueil des Urgences, Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur
  • Haguenau, France, 67500
    • Service d'Accueil des Urgences, Centre Hospitalier de Haguenau
  • Mulhouse, France, 68051
    • Service des Urgences, CH Emile Muller
  • Selestat, France, 67606
    • Service des Urgences, Centre Hospitalier de Sélestat
  • Strasbourg, France, 67091
    • Service d'Accueil des Urgences, Nouvel Hôpital Civil
  • Strasbourg, France, 67091
    • Service de Réanimation Médicale, Nouvel Hôpital Civil
  • Strasbourg, France, 67098
    • Service de Réanimation Médicale, Hôpital de Hautepierre
  • Strasbourg, France, 67098
    • Service des Urgences, Hôpital de Hautepierre
  • Wissembourg, France, 67160
    • Service des Urgences, Centre Hospitalier Intercommunal de la Lauter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Pascal BILBAULT, MD, Hopitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: September 20, 2012
• First Posted (Estimate): September 25, 2012

Study Record Updates

• Last Update Posted (Estimate): March 3, 2016
• Last Update Submitted That Met QC Criteria: March 2, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Drug Overdose
• Other Study ID Numbers: 5313

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No