Acetaminophen OverdoseNCT01692639
Acute Acetaminophen Ingestion: Does Repeated Acetaminophen Blood Test Have an Interest?
An observational study of Acetaminophen Overdose, run by University Hospital, Strasbourg, France at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetaminophen Overdose
- How many people
- 4 participants
- Where
- 10 sitesFrance
- Study dates
- May 2013to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients over 18 years
- Having taken a single dose of acetaminophen
- With a supposed ingested dose over 4 grams
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Centre Hospitalier Gérontologique
Bischwiller, 67241
Service d'accueil des Urgences, Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur
Colmar, 68024
Service d'Accueil des Urgences, Centre Hospitalier de Haguenau
Haguenau, 67500
Service des Urgences, CH Emile Muller
Mulhouse, 68051
Service des Urgences, Centre Hospitalier de Sélestat
Sélestat, 67606
Service d'Accueil des Urgences, Nouvel Hôpital Civil
Strasbourg, 67091
Service de Réanimation Médicale, Nouvel Hôpital Civil
Strasbourg, 67091
Service de Réanimation Médicale, Hôpital de Hautepierre
Strasbourg, 67098
Service des Urgences, Hôpital de Hautepierre
Strasbourg, 67098
Service des Urgences, Centre Hospitalier Intercommunal de la Lauter
Wissembourg, 67160
About this study
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startMay 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetaminophen OverdoseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal BILBAULT, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692639
- Sponsor's protocol ID
- 5313
- Status last verified
- Mar 2016
- First submitted
- 19 Sep 2012
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Acetaminophen Ingestion: Does Repeated Acetaminophen Blood Test Have an Interest?
- ClinicalTrials.gov ID
- NCT01692639
- Acronym / sponsor ID
- 5313
- Conditions
- Acetaminophen Overdose
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients over 18 years
- Having taken a single dose of acetaminophen
- With a supposed ingested dose over 4 grams
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal BILBAULT, MD principal investigator
Hôpitaux Universitaires de Strasbourg
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acetaminophen Overdose, run by University Hospital, Strasbourg, France at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.