Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised Trial to Assess the Effectiveness of Pre-treatment With Ondansetron at Reducing Nausea and Vomiting in Patients Treated With Either the Conventional Regimen or a Modified Regimen of Acetylcysteine for Paracetamol Poisoning
Brief Summary: This study is designed to assess the impact of new approaches to therapy for paracetamol poisoning. Standard therapy is currently acetylcysteine by intravenous infusion over 20.25h. This regimen is given to those deemed "at risk" using standard criteria (British National Formulary 200920). It has 3 major problems, adverse events (nausea and vomiting and anaphylactoid reactions), therapy duration and complexity of administration.

This study is primarily designed to test the efficacy of prophylactic anti-emetic therapy.

It will also provide sufficient experience and data from a modified shortened IV acetylcysteine regimen to adequately design and power a study of the modified regimen as a new treatment for this common poison. Such an approach has a major potential to reduce patient adverse events from acetylcysteine therapy and shorten duration of hospital stay.


Options:
A: Inclusion Criteria:

* Patients with severe or sub-severe hepatitis, with an indication or a contraindication to liver transplantation

Exclusion Criteria:

* Sepsis severe not controlled
* Haemorrhage activates not controlled
* Clinical Obviousness of disseminated intravascular coagulation
* Severe Pathology cardiopulmonary (NYHA \> or = 2)
* Pregnancy, breast feeding
* Average blood Pressure \< 40 mmHg more than 10 minutes in spite of a support by the inotrope
* Nonhepatic coma of origin
* Cholestases extra-hepatitic
* Antecedents of heavy surgery in the 4 previous weeks or surgical problems unsolved
* Absolute counter-indication with hepatic transplantation (extra Neoplasia hepatic evolutionary, irreversible cerebral Attack, irreversible multi-visceral Failure, visceral tares contra-indicating the transplantation)
* Positive serology HIV
* Hepatic Demonstrations of the malignant hemopathies
* Participation in another therapeutic test in the 4 previous weeks
B: Inclusion Criteria:

* Individuals who self-report consuming at least 6 drinks per day, daily, for at least 6 weeks and who are currently enrolled at the Detoxification Center, Hotel Dieu Hospital.
* Last alcohol consumption occurring between 12 and 72 hours prior to screening for study.

Exclusion Criteria:

* Individuals with a self-reported or previously documented history of hepatitis A, B, C or HIV.
* Individuals who have ingested any acetaminophen regardless of dose in the previous 48 hours.
* Individuals who have ingested \> 4 grams of acetaminophen/day in any of the previous 7 days.
* Individuals \< 18 years of age.
* Individuals with abnormal liver function at baseline (defined as AST or ALT \> 120 IU/L, International Normalized Ratio \[INR\] \> 1.5, and a-GST \> 7.5 7 :g/L).
* Individuals who have an allergy or sensitivity to acetaminophen.
C: ALF Inclusion Criteria:

* Written Informed consent from patient's next of kin
* Altered mentation of any degree (encephalopathy)
* Evidence of moderately severe coagulopathy (INR ≥ 1.5)
* A presumed acute illness onset of less than 26 weeks
* The NIH guidelines on the inclusion of women and minorities as subjects in clinical research will be observed

ALF Exclusion Criteria:

* Cirrhosis patients
* Alcohol induced liver failure
* Known pre-existing chronic liver disease

ALI Inclusion Criteria:

Acetaminophen (APAP) etiology: acute illness \< 2 wks

* INR ≥ 2.0, ALT ≥ 10X ULN Non-acetaminophen etiology: acute illness \< 26 wks
* INR≥ 2.0, ALT≥ 10X ULN, TBili ≥ 3 mg/dl

ALI Exclusion Criteria:

• Altered mentation of any degree (encephalopathy)
D: Inclusion Criteria:

* Any patient admitted to hospital within 36 hours of a single acute paracetamol overdose; AND
* Requires treatment with acetylcysteine.

These patients will include:

* Patients with no risk factors and timed paracetamol concentrations above the 200-line on the UK paracetamol overdose treatment nomogram.
* Patients with at least 1 risk factor and timed paracetamol concentrations above the 100-line on the UK paracetamol overdose treatment nomogram
* Patients presenting \>8 hours, and at risk of liver damage based on history of dose ingested (BNF) that need immediate treatment

Risk factors are defined as follows:

* Nutritional deficiency, malnourished and/or debilitating disease: acute or chronic starvation, eating disorders, cachexia, malabsorption syndromes, AIDS, cystic fibrosis, hepatitis C, chronic alcoholism.
* Enzyme induction: use of drugs with this property (carbamazepine, rifampicin, barbiturates, phenytoin, rifabutin, efavirenz, nevirapine, St John's Wort; regular consumption of ethanol above advised amounts.

Exclusion Criteria:

Patients:

* \< 16 years old
* Detained under the Mental Health Act
* With known permanent cognitive impairment
* With a life-threatening illness
* Who are known to be pregnant
* Who have previously participated in the study
* Unreliable history of paracetamol overdose
* Vomiting and requiring treatment antiemetic prior to randomisation
* Presenting after 36 hours of a single acute paracetamol overdose
* Presenting after taking a staggered paracetamol overdose (defined as when the overdose of paracetamol is taken over a period of more than 2 hours)
* Who take anticoagulants (e.g. warfarin) therapeutically or have taken an overdose of anticoagulants
* Who, in the opinion of the responsible clinician/nurse, are unlikely to complete the full course of acetylcysteine e.g. expressing wish to self-discharge
* Who in the opinion of the responsible clinician/nurse are unable to complete the initial questionnaire either themselves or with nurse assistance.
* Who have a history of hypersensitivity to 5HT3 antagonists
* Non-English speaking patients. (Trial information material will only be produced in English in view of the known and stable demographic of the Edinburgh and Newcastle self harm population)

Answer: D