The Effect of a Large-volume Paracentesis on Fatigue, Sleep, and Quality of Life in Cirrhosis
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.
Diuretic-Resistant Refractory Ascites
Procedure: Large Volume Paracentesis
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of a Large-volume Paracentesis on Fatigue, Sleep, and Quality of Life in Cirrhosis|
- Fatigue [ Time Frame: 10 min ] [ Designated as safety issue: No ]Patients undergo 6-minute walk test and fill out Fisk Impact Scale (Fatigue Questionnaire)
- Hepatic Encephalopathy [ Time Frame: 10 min ] [ Designated as safety issue: No ]Patients undergo psychometric testing that involves Trail Making Test and Digit Symbol Substitution Test.
- Quality of Life [ Time Frame: 5 min ] [ Designated as safety issue: No ]Patients fill out Medical Outcomes Study Short Form 36 questionnaire
- Daytime Sleepiness [ Time Frame: 5 min ] [ Designated as safety issue: No ]Patients fill out Epworth Sleepiness Scale questionnaire.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Fatigue Impact Scale questionnaire, 6-minute walk test
Procedure: Large Volume Paracentesis
procedure done to remove large volume of ascitic fluid that has collected in the peritoneum.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777971
|Contact: Samuel Sigal, MDemail@example.com|
|United States, New York|
|New York University School of Medicine||Recruiting|
|New York, New York, United States, 10016|
|Contact: Samuel Sigal, MD 212-263-0102 firstname.lastname@example.org|
|Principal Investigator: Samuel Sigal, MD|
|Sub-Investigator: Omer Ilyas, MD|
|Sub-Investigator: Rabia Ali, MD|
|Principal Investigator:||Samuel Sigal, MD||New York University School of Medicine|