All patients enrolled into the ALFSG Registry with the duration of illness <26 weeks with (1) severe acute liver injury; International Normalized Ratio (INR) ≥2.0) and not related to acetaminophen overdose, with no evidence of hepatic encephalopathy (HE); and (2) acute liver failure; INR ≥1.5 with presence of any degree of HE will perform the Breath Test.

Acute Liver Failure

The test substrate in this study, ¹³C-methacetin solution for single-use oral administration (75 mg in 150 ml purified water), is administered orally or via feeding tube, rapidly absorbed, exclusively metabolized by hepatic mixed function oxidase via O-demethylation, mainly by cytochrome P450 enzyme, subtype 1A2, into acetaminophen and formaldehyde. The formaldehyde is then transformed through two successive oxidative steps to ¹³carbon dioxide, the quantity of which is measured in exhaled breath as a ratio of 13C to 12C.
The nasal or intubated breath sampling investigational device (ID) circuit continuously transports the breath sample from the patient to the BreathID® MCS device before and following administration of the 13C-methylacetanilide test substrate.

13C-Methacetin

University of Alabama, Birmingham

University of California, San Francisco

Yale University School of Medicine

Northwestern University

University of Kansas Medical Center

University of Michigan

Ohio State University Medical Center

Medical University of South Carolina

UT Southwestern Medical Center at Dallas

VCU Medical Center

University of Washington Medical Center

13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF

13C-Methacetin Breath Test for the Prediction of Outcome in in Acute Liver Injury or Acute Liver Failure

This outcome requires only one measurement per subject and examines whether the distributions (means) of enrollment PDRPeak values vary between those that spontaneously survive at Day 21 and those that either die or get a transplant by Day 21.

Using changes in PDRPeak between day 1 and day 2, we will determine whether positive change in PDRpeak more effectively allows separation between those that do and do not spontaneously survive at Day 21.

Using changes in PDRPeak between day 1 and day 3, we will determine whether positive change in PDRpeak more effectively allows separation between those that do and do not spontaneously survive at Day 21.

Using changes in PDRPeak between day 1 and day 5, we will determine whether positive change in PDRpeak more effectively allows separation between those that do and do not spontaneously survive at Day 21.

De-identified data for the overall study will be shared once the study is completed.

William Lee

Professor

University of Texas Southwestern Medical Center

Exalenz Bioscience LTD.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Cirrhosis

Department of Veteran Affairs

Virginia Commonwealth University

Hadassah Medical Organization

Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics

Use of the BreathID to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients With Cirrhosis in Need of Liver Transplantation

US Department of Veterans Affairs

acetamide

atrofi

atrophy

acetamide/atrofi

13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF

Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics

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