a study on Liver Failure
The ALF-MBT protocol is for a multicenter, open label, non-randomized study to determine the value of Breath Identification® (BreathID®) Acute Liver Failure 13C-Methacetin Breath Test System in predicting the outcome of patients diagnosed with acute liver failure who meet inclusion/exclusion criteria. Up to 200 evaluable patients will be enrolled. An evaluable patient is one who has completed one or more breath tests for at least 30 minutes after administration of the 13C-Methacetin solution (test substrate). The Breath Test will be performed on all patients upon admission into the study (Day 1) and repeated on Days 2, 3, 5 and 7 provided no contra-indications are present. Each test continuously measures changes in the metabolism of the 13C-Methacetin in order to assess the improvement or deterioration in liver metabolic function about improvement or deterioration in liver metabolic function. Patients will be contacted for the Day 21 follow up (21 days after enrollment into the trial) to determine spontaneous survival, transplantation and occurrence of serious adverse events since the patient's last study treatment.
13C-Methacetin Breath Test for the Prediction of Outcome in Acute Liver Failure
The importance of identifying the patient with ALF who is likely to die without a liver transplant cannot be overstated and has remained a primary focus of clinical investigation for 25 years. Traditional scoring systems and prognostic models, such as King's College Criteria (KCC), Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II), currently used to monitor patients with ALF lack individual sensitivity and specificity and do not provide direct information about the liver's metabolic function, which is a key variable in assessing liver status and potential disease progression versus recovery in ALF patients. Despite recent advances used by the ALFSG Prognostic Index (ALFSG-PI) and Model for End-Stage Liver Disease (MELD), better predictive modalities are still needed.
The 13C-Methacetin breath test is a rapid, reproducible, point-of-care test of liver metabolic function. After oral or nasogastric tube administration, the 13C labeled Methacetin is O-demethylated by cytochrome P4501A2 in the liver and further biotransformed into 13CO2, which is expired in breath. The BreathID® MCS device captures and quantifies expired 13CO2 and standardizes recovery against expired 12CO2 through a nasal cannula (in conscious patients) or an adaptor connected to the ventilator line (for intubated patients). The results obtained from the device are expressed as delta over baseline (DOB), which expresses the change in 13CO2/12CO2 ratio in comparison to the baseline measurement. It can be transformed into the percentage of 13C dose recovered over time (PDR) after the ingestion of Methacetin, and the cumulative PDR (CPRD), the rate at which 13C substrate is metabolized, derived from the breath 13C/12C ratio.
This is a multicenter, open label, non-randomized study of the ALF-MBT to assess functional trends of liver metabolism in patients diagnosed with ALF. Up to 200 evaluable male and female patients with acute liver failure present at the time of enrollment into the ALFSG Registry will be consecutively enrolled. An evaluable patient is one who has completed one or more ALF-MBTs measured for a minimum of 30 (and ideally 60) minutes after administration of 13C-Methacetin. Study sites will include up to 12 of the clinical sites located in the United States that are involved in the Acute Liver Failure Study Group.
The ALF-MBT will be performed on all patients upon admission into the study (Day 1) and repeated on Days 2, 3, 5 and 7, as close to the same time of day as possible (within ± 4 hours), provided no contra-indications are present. Subjects will be contacted for the Day 21 follow up (21 days after the subject's enrollment into the trial) to determine spontaneous survival, transplantation and occurrence of serious adverse events since the subject's last study treatment.
Acute Liver Failure methacetin breath test severe acute liver injury hepatic encephalopathy ALFSG Registry acetaminophen toxicity Acetaminophen
Open to people ages 18–70
STOP-ALF) precludes enrollment in ALF-MBT Study) (Note: Participation in observatory studies is not an exclusion.)
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