Crabb et al listed events that are important for a patient with alcoholic hepatitis. These are important to capture in a clinical trial. The authors are from multiple institutions in the United States and the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Patient selection: alcoholic hepatitis, with or without cirrhosis
Most important events of interest:
(1) acute kidney injury
(2) upper gastrointestinal tract bleeding (variceal or nonvariceal)
(3) hepatic encephalopathy
(4) diuretic-resistant ascites
(5) drug-induced liver injury (DILI), presenting as unexpected elevation of liver function tests
(6) infection
(7) hyponatremia (from Table 3)
Infections that can occur in a patient with alcoholic hepatitis:
(1) spontaneous or secondary bacterial peritonitis
(2) urinary tract infection
(3) pneumonia
(4) cellulitis
(5) infectious diarrhea (Clostridium difficile, other)
(6) intra-abdominal infection
(7) sepsis
Additional items that may be of interest:
(1) concurrent hepatitis (HBV, HCV, NASH)
(2) anemia
(3) coagulopathy
(4) malnutrition
(5) myopathy
(6) trauma
(7) edema (from Table 3)
(8) hypotension (from Table 3)