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

This study is currently recruiting participants.
Verified July 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01692639
First received: September 19, 2012
Last updated: July 16, 2013
Last verified: July 2013
  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:

Estimated Enrollment: 200
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692639

Contacts
Contact: Pascal BILBAULT, MD 33.3.88.12.82.21 pascal.bilbault@chru-strasbourg.fr
Contact: Pierre PERESSON 33.3.06.78.82.47.22 pierre.peresson@orange.fr

Locations
France
Centre Hospitalier Gérontologique Recruiting
Bischwiller, France, 67241
Contact: Christophe BERNA, MD    33.3.06.32.65.31.87    Christophe.berna@free.fr   
Principal Investigator: Christophe BERNA, MD         
Service d'accueil des Urgences, Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur Recruiting
Colmar, France, 68024
Contact: Eric THIBAUD, MD    33.3.89.12.41.80    ethibaud@yahoo.fr   
Principal Investigator: Eric THIBAUD, MD         
Sub-Investigator: GERSTL-HINSCHBERGER Laure, MD         
Sub-Investigator: KEMPF Nicolas, MD         
Sub-Investigator: GETE Etienne, MD         
Sub-Investigator: SAVINEAU-RAETH Jean-Remy, MD         
Sub-Investigator: DUSSAU Leslie, MD         
Sub-Investigator: ZINK Jean-Christophe, MD         
Sub-Investigator: PATARIN Christelle, MD         
Sub-Investigator: Jean-Jacques OTT, MD         
Service d'Accueil des Urgences, Centre Hospitalier de Haguenau Recruiting
Haguenau, France, 67500
Contact: Corina DUJA, MD    33.3..88.06.33.55    corina-mihaela.duja@ch-haguenau.fr   
Principal Investigator: Corina DUJA, MD         
Service des Urgences, CH Emile Muller Recruiting
Mulhouse, France, 68051
Contact: Loïc LAVAILL, MD    33.3.89.64.66.09    kacems@ch-mulhouse.fr   
Principal Investigator: Loïc LAVAILL, MD         
Service des Urgences, Centre Hospitalier de Sélestat Recruiting
Selestat, France, 67606
Contact: Thomas WEISS, MD    33.3.06.72.77.59.91    thomas.weiss@ch-selestat.fr   
Principal Investigator: Thomas WEISS, MD         
Service de Réanimation Médicale, Nouvel Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Michel HASSELMANN, MD    33.3.69.55.11.23    michel.hasselmann@chru-strasbourg.fr   
Principal Investigator: Michel HASSELMANN, MD         
Sub-Investigator: DELABRANCHE Xavier, MD         
Sub-Investigator: BERGER Asaël, MD         
Sub-Investigator: KUMMERLEN Christine, MD         
Sub-Investigator: NEAGU Anca Raluca, MD         
Sub-Investigator: SCHNELL David, MD         
Service d'Accueil des Urgences, Nouvel Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Eric BAYLE, MD    33.3.69.55.10.45    eric.bayle@chru-strasbourg.fr   
Principal Investigator: Eric BAYLE, MD         
Service de Réanimation Médicale, Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Francis SCHNEIDER, MD    33.3.88.12.79.22    francis.schneider@chru-strasbourg.fr   
Principal Investigator: Francis SCHNEIDER, MD         
Sub-Investigator: Jean-Etienne HERBRECHT, MD         
Sub-Investigator: CASTELAIN Vincent, MD         
Sub-Investigator: SCHENCK Maleka, MD         
Sub-Investigator: JANSSEN-LANGENSTEIN Ralf, MD         
Sub-Investigator: GUILLOT Max, MD         
Sub-Investigator: HARLAY Marie-Line, MD         
Sub-Investigator: DIOUF Mamadou Mansour, MD         
Sub-Investigator: LUTUN Philippe, MD         
Service des Urgences, Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Pascal BILBAULT, MD    33.3.88.12.82.21    pascal.bilbault@chru-strasbourg.fr   
Contact: Pierre PERESSON    33.3.06.78.82.47.22    pierre.peresson@orange.fr   
Principal Investigator: Pascal BILBAULT, MD         
Sub-Investigator: Maud GANDOIN, MD         
Sub-Investigator: Mihaela DANCIU, MD         
Sub-Investigator: Michel BOUCON, MD         
Sub-Investigator: Ruxandra Aimée COJOCARU, MD         
Sub-Investigator: Claire KAM, MD         
Service des Urgences, Centre Hospitalier Intercommunal de la Lauter Recruiting
Wissembourg, France, 67160
Contact: Didier WINGERT, MD    33.3.88.54.11.38    dwingert@ch-wissembourg.fr   
Principal Investigator: Didier WINGERT, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Pascal BILBAULT, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

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: July 16, 2013
Health Authority: France:France: Institutional Ethical Committee.
France: The Commission nationale de l’informatique et des libertés

Additional relevant MeSH terms:
Overdose
Poisoning
Substance-Related Disorders
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014