The Effect of a Large-volume Paracentesis on Fatigue, Sleep, and Quality of Life in Cirrhosis

The study design is a prospective observational analysis. Subjects who have been deemed candidates for a large-volume paracentesis, based on clinical criteria and who meet the above-referenced inclusion and exclusion criteria will be recruited to participate in this study. Study visits will take place on 2 consecutive days. Each study visit will last approximately 2 to 3 hours. The first assessment day will occur immediately prior to an electively-scheduled large-volume paracentesis. The second assessment will occur one day later. Once enrolled, all subjects will undergo a baseline assessment of liver function. Medical records will be reviewed to determine etiology of cirrhosis, history of variceal bleeding, history of spontaneous bacterial peritonitis, history of hospitalization for hepatic encephalopathy, and use of and clinical response to treatment with lactulose, neomycin, and/or rifaximin. Body mass index and grade of ascites (grade 1, mild ascites; grade 2, moderate ascites; grade 3, massive or tense ascites) will be determined based on physical examination. History or presence of asterixis will be recorded. Severity of hepatic encephalopathy will be graded according to the West-Haven criteria and further assessed by neuropsychological testing (discussed in further detail below). Baseline serum laboratory analyses will be obtained, including the following: aspartate aminotransferase, alanine aminotransferase, total bilirubin, albumin, blood urea nitrogen, creatinine, prothrombin time and international normalized ratio, and platelet count. Based on these serum studies, the Child-Pugh score and Model for End-Stage Liver Disease score will be calculated. After baseline assessments are obtained, the six-minute walk test and a series of questionnaires (discussed in further detail below) to assess fatigue, sleep, and quality of life will be performed on study day 1, immediately prior to the paracentesis, and then repeated one day after the paracentesis. Note that neither the six-minute walk test nor the neuropsychological testing or questionnaires are considered standard of care for patients requiring large-volume paracentesis and these will be performed exclusively for research purposes.