Breath Test for Patients with Acute Liver Disease for early Detection of the Need for Transplant or Recovery

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 112

Inclusion Criteria

1.Adult men or women (>18 years of age).
2.Acute Liver insult
3.No evidence of cirrhosis (unless clinical acute Wilsons)
4.INR > 1.8
5.Duration of illness < 12 and 24 weeks

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patient with any chronic liver disease
2.Patient has severe congestive heart failure
3.Patient has severe pulmonary hypertension
4.Patient has chronic renal insufficiency with severe cardiac disease
5.Patient has previous surgical bypass surgery for morbid obesity
6.Patient has extensive small bowel resection
7.Patient with any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication
8.Patient is a recipient of any organ transplant
9.Patient with proven or suspected hepatocellular carcinoma
10.Patient is pregnant
11.Patient allergic to acetaminophen (such as Tylenol or any other related medications)
12.Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma
13.Patients with septic cholestasis
14. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs
15.Patients that are taking hepatotoxin drugs
16.Patient, based on the opinion of the investigator, should not be enrolled into this study
17.Patients unable or unwilling to sign informed consent
18.Patients that are participating in other clinical trials evaluating experimental treatments or procedures

Exclusion Criteria (Day of MBT)

1.Patient has not fasted for 8 hours
2.Patient has smoked on the day of the test
3.Patient that has taken drugs that can interfere with methacetin metabolism : fluvoxamine, amiodarone, ciprofloxacin, cimetidine, rifampin, carbamazepine within the last 24 hours
4.Patient has taken Tylenol or any other acetaminophen related medications within the past 24 hours
5.Patients that received general anesthesia or conscious sedation in the last 24 hours
6.Patient has consumed alcohol within the past 24 hours
7.Patients that still suffer from any previous clinical intervention (e.g. biopsy)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Unknown Status

Hadassah Medical Organization

Posted 9/16/2011