Acute Liver FailureNCT01435421
Breath Test for Patients With Acute Liver Disease for Early Detection of the Need for Transplant or Recovery
An observational study of Acute Liver Failure, run by Hadassah Medical Organization.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Liver Failure
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that are hospitalaized.
Who may be able to join
- 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 -
Who cannot join
- 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
Show all 14Show fewer
- 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 -
About this study
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.
Read more
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.
- Conditions
- Acute Liver Failure
- Medical subject headings
- Liver Failure, Acute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Liver FailureStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435421
- Sponsor's protocol ID
- ALF-BID-1108-HMO-CTIL
- Status last verified
- Sep 2011
- First submitted
- 15 Sep 2011
- Last updated
- 16 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Test for Patients With Acute Liver Disease for Early Detection of the Need for Transplant or Recovery
- ClinicalTrials.gov ID
- NCT01435421
- Acronym / sponsor ID
- ALF-BID-1108-HMO-CTIL
- Conditions
- Acute Liver Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (estimated)
- First posted
- 16 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are hospitalaized.
Key inclusion criteria (5 listed)
- 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 -
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Liver Failure, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2011.