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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01692639
First received: September 19, 2012
Last updated: March 2, 2016
Last verified: March 2016
  Purpose
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?

Condition
Acetaminophen Overdose

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acute Acetaminophen Ingestion: Does Repeated Acetaminophen Blood Test Have an Interest?

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Enrollment: 4
Study Start Date: May 2013
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692639

Locations
France
Centre Hospitalier Gérontologique
Bischwiller, France, 67241
Service d'accueil des Urgences, Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur
Colmar, France, 68024
Service d'Accueil des Urgences, Centre Hospitalier de Haguenau
Haguenau, France, 67500
Service des Urgences, CH Emile Muller
Mulhouse, France, 68051
Service des Urgences, Centre Hospitalier de Sélestat
Selestat, France, 67606
Service d'Accueil des Urgences, Nouvel Hôpital Civil
Strasbourg, France, 67091
Service de Réanimation Médicale, Nouvel Hôpital Civil
Strasbourg, France, 67091
Service de Réanimation Médicale, Hôpital de Hautepierre
Strasbourg, France, 67098
Service des Urgences, Hôpital de Hautepierre
Strasbourg, France, 67098
Service des Urgences, Centre Hospitalier Intercommunal de la Lauter
Wissembourg, France, 67160
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Pascal BILBAULT, MD Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01692639     History of Changes
Other Study ID Numbers: 5313 
Study First Received: September 19, 2012
Last Updated: March 2, 2016
Health Authority: France:France: Institutional Ethical Committee.
France: The Commission nationale de l’informatique et des libertés

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics

ClinicalTrials.gov processed this record on September 29, 2016