Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 13C-Methacetin Breath Test for the Prediction of Outcome in Acute Liver Failure
Brief Summary:
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.