Breath Test for Patients With Acute Liver Disease for Early Detection of the Need for Transplant or Recovery
Primary Purpose
Acute Liver Failure
Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Acute Liver Failure
Eligibility Criteria
Inclusion Criteria:
- Adult men or women (>18 years of age).
- Acute Liver insult
- No evidence of cirrhosis (unless clinical acute Wilsons)
- INR > 1.5
- Duration of illness < 24 weeks -
Exclusion Criteria:
- Patient with any chronic liver disease
- Patient has severe congestive heart failure
- Patient has severe pulmonary hypertension
- Patient has chronic renal insufficiency with severe cardiac disease
- Patient has previous surgical bypass surgery for morbid obesity
- Patient has extensive small bowel resection
- Patient with established extra-hepatic auto-immune disease on long term treatment
- Patient is a recipient of any organ transplant (within the last 3 months)- Patient with proven or suspected hepatocellular carcinoma
- Patient is pregnant
- Patient allergic to paracetamol (such as Tylenol or any other related medications)
- Patients in whom oral intake is contra-indicated
- Patient, based on the opinion of the investigator, should not be enrolled into this study
- Patients or their nominated representative is unwilling to sign informed consent
- Patients that are participating in other clinical trials evaluating experimental treatments or procedures, not including observatory trials -
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01435421
First Posted
September 15, 2011
Last Updated
September 15, 2011
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01435421
Brief Title
Breath Test for Patients With Acute Liver Disease for Early Detection of the Need for Transplant or Recovery
Official Title
Breath Test for Patients With Acute Liver Disease for Early Detection of the Need for Transplant or Recovery
Study Type
Observational
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
Brief Summary
Acute liver failure (ALF) results from an abrupt loss of hepatic metabolic and synthetic function and leads to encephalopathy and potentially multi-organ dysfunction. Aetiologies include autoimmune and metabolic diseases, infectious agents and hepatotoxins. Worldwide, infectious hepatitis (A, B and E) is the most common cause. In Western Europe and the USA, ALF is most frequently caused by paracetamol intoxication.
The MBT can produce immediate results to aid in decision making in patients with acute liver disease. Such a test may affect decision-making regarding transplantation in this setting, facilitate appropriate discharge from critical care to other hospital units and to home, provide point of care assessment of therapeutic interventions.
The BreathID can potentially help in determining:
Parameter to include patients in transplant list (the UNOS 1A group)
Identification that patient deteriorates and needs extended hospitalization/referral to ICU/change in management
An addition to the MELD and or other scores to estimate risk in other acute patients
Additional information to that of other commonly utilized prognostic scoring systems
The primary end-point of the study is to develop a model to predict deterioration of the liver disease, which incorporates measurements from the MBT along with other potential variables. The data collected will be used to develop a prediction model using data-mining methodology (linear and non-linear regression models, binary trees, neural networks, etc…). The predictive models may include measurements from the MBT, blood test results, as single measurements or as trend over time. The model that will be developed, will attempt to predict the disease deterioration vs. recovery accurately, at an earlier time point than the standard procedure. A threshold will then be determinate based on adequate sensitivity and specificity levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Liver Failure
7. Study Design
Enrollment
112 (Anticipated)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult men or women (>18 years of age).
Acute Liver insult
No evidence of cirrhosis (unless clinical acute Wilsons)
INR > 1.5
Duration of illness < 24 weeks -
Exclusion Criteria:
Patient with any chronic liver disease
Patient has severe congestive heart failure
Patient has severe pulmonary hypertension
Patient has chronic renal insufficiency with severe cardiac disease
Patient has previous surgical bypass surgery for morbid obesity
Patient has extensive small bowel resection
Patient with established extra-hepatic auto-immune disease on long term treatment
Patient is a recipient of any organ transplant (within the last 3 months)- Patient with proven or suspected hepatocellular carcinoma
Patient is pregnant
Patient allergic to paracetamol (such as Tylenol or any other related medications)
Patients in whom oral intake is contra-indicated
Patient, based on the opinion of the investigator, should not be enrolled into this study
Patients or their nominated representative is unwilling to sign informed consent
Patients that are participating in other clinical trials evaluating experimental treatments or procedures, not including observatory trials -
Study Population Description
Patients that are hospitalaized.
Sampling Method
Non-Probability Sample
12. IPD Sharing Statement
Learn more about this trial
Breath Test for Patients With Acute Liver Disease for Early Detection of the Need for Transplant or Recovery
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