Breath Test for Patients With Acute Liver Disease for Early Detection of the Need for Transplant or Recovery
|ClinicalTrials.gov Identifier: NCT01435421|
Recruitment Status : Unknown
Verified September 2011 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : September 16, 2011
Last Update Posted : September 16, 2011
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.
|Condition or disease|
|Acute Liver Failure|
|Study Type :||Observational|
|Estimated Enrollment :||112 participants|
|Official Title:||Breath Test for Patients With Acute Liver Disease for Early Detection of the Need for Transplant or Recovery|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||December 2012|