The Effect of a Large-volume Paracentesis on Fatigue, Sleep, and Quality of Life in Cirrhosis
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|ClinicalTrials.gov Identifier: NCT01777971|
Recruitment Status : Withdrawn
First Posted : January 29, 2013
Last Update Posted : August 4, 2015
Ascites is the accumulation of fluid within the peritoneal cavity of the abdomen. It is a frequent complication of cirrhosis that is associated with significant morbidity and poor quality of life. Large-volume ascites has been associated with impaired pulmonary function. In a previous study, the presence and severity of ascites were determined to be significant determinants of fatigue.
In this study, we will determine whether large-volume ascites contributes to fatigue by assessing the response to drainage of ascites by means of a procedure called large-volume paracentesis. We hypothesize that treatment of ascites with a single large-volume paracentesis leads to decreased fatigue and improved quality of life and that this improvement is associated with improved sleep pattern.
20 patients with cirrhosis with refractory ascites requiring regular drainage of ascites fluid by large-volume paracenteses will be recruited for the study. All patients will undergo a complete clinical and physical examination for liver function, including blood tests. Hepatic encephalopathy, a change in mental status associated with liver dysfunction, will be assessed by obtaining historical data and by means of simple bedside neuropsychological examinations.
Study visits will take place on two consecutive days, with each visit lasting approximately 2-3 hours. Immediately prior to a large-volume paracentesis, patients will complete standardized questionnaires for fatigue severity, quality of life, quality of sleep, and a physical assessment of fatigue by means of a 6-minute walk test. Repeat evaluations will be performed 1 day after the procedure. Statistical analysis will then be performed to determine the effect of the paracentesis on the various clinical assessments.
|Condition or disease|
|Cirrhosis Hepatic Encephalopathy Ascites Fatigue|
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||The Effect of a Large-volume Paracentesis on Fatigue, Sleep, and Quality of Life in Cirrhosis|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Patients with cirrhosis
Male and female subjects who have cirrhosis of the liver and diuretic-resistant ascites (based on International Ascites Clib criteria) and have been evaluated and approved to have a large-volume paracentesis as part of standard of care treatment.
- Fatigue [ Time Frame: 10 min ]Patients undergo 6-minute walk test and fill out Fisk Impact Scale (Fatigue Questionnaire)
- Hepatic Encephalopathy [ Time Frame: 10 min ]Patients undergo psychometric testing that involves Trail Making Test and Digit Symbol Substitution Test.
- Quality of Life [ Time Frame: 5 min ]Patients fill out Medical Outcomes Study Short Form 36 questionnaire
- Daytime Sleepiness [ Time Frame: 5 min ]Patients fill out Epworth Sleepiness Scale questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777971
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Samuel Sigal, MD||NYU Langone Health|