Breath Test for Patients With Acute Liver Disease for Early Detection of the Need for Transplant or Recovery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01435421
First received: September 15, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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
Acute Liver Failure

Study Type: Observational
Official Title: Breath Test for Patients With Acute Liver Disease for Early Detection of the Need for Transplant or Recovery

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 112
Study Start Date: October 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients that are hospitalaized.

Criteria

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 > 1.5
  5. Duration of illness < 24 weeks -

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 established extra-hepatic auto-immune disease on long term treatment
  8. Patient is a recipient of any organ transplant (within the last 3 months)- Patient with proven or suspected hepatocellular carcinoma
  9. Patient is pregnant
  10. Patient allergic to paracetamol (such as Tylenol or any other related medications)
  11. Patients in whom oral intake is contra-indicated
  12. Patient, based on the opinion of the investigator, should not be enrolled into this study
  13. Patients or their nominated representative is unwilling to sign informed consent
  14. Patients that are participating in other clinical trials evaluating experimental treatments or procedures, not including observatory trials -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01435421     History of Changes
Other Study ID Numbers: ALF-BID-1108-HMO-CTIL
Study First Received: September 15, 2011
Last Updated: September 15, 2011
Health Authority: Israel: Ministry of Health - Director General

Additional relevant MeSH terms:
Liver Diseases
Liver Failure
Liver Failure, Acute
Digestive System Diseases
Hepatic Insufficiency

ClinicalTrials.gov processed this record on July 28, 2014