The Effect of a Large-volume Paracentesis on Fatigue, Sleep, and Quality of Life in Cirrhosis
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Purpose
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 | Intervention |
|---|---|
|
Cirrhosis Hepatic Encephalopathy Diuretic-Resistant Refractory Ascites Fatigue |
Procedure: Large Volume Paracentesis |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fatigue
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 peritonium.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects with cirrhosis (based on clinical, laboratory, radiologic evaluation, and liver biopsy, when available) with diuretic-resistant refractory ascites, based on International Ascites Club criteria.[2,31] Specific criteria used for inclusion will be subjects with ascites that cannot be stabilized despite intensive diuretic therapy (e.g., 400 mg of spironolactone with 160 mg of furosemide per day) and dietary sodium restriction (90 mmol of sodium per day) with reappearance of grade 2 or 3 ascites within 4 weeks of mobilization (defined as decrease of ascites at least to grade 1). All subjects must provide separate written consent to undergo a large-volume paracentesis.
Exclusion Criteria:
Subjects will not be eligible for the study if they: (1) have been hospitalized in the previous 1 month for gastrointestinal bleeding, infection, or renal failure; (2) are unable to independently ambulate or have had unstable angina or myocardial infarction within the previous 1 month, as these are contraindications to participating in the 6-minute walk test; (3) are unable to participate in neuropsychological tests or questionnaires; (4) are receiving interferon therapy; (5) have a history of alcohol abuse within the previous 6 months; (6) have a diagnosis of a primary neurologic disorder or uncontrolled psychiatric disorder; or (7) are receiving psychotropic medications such as benzodiazepines and anti-epileptic drugs.
Contacts and Locations| Contact: Samuel Sigal, MD | 212-263-0102 | samuel.sigal@nyumc.edu |
| 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 samuel.sigal@nyumc.edu | |
| 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 |
More Information
No publications provided
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01777971 History of Changes |
| Other Study ID Numbers: | R11-00672 |
| Study First Received: | January 24, 2013 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: New York University School of Medicine Institutional Review Board |
Additional relevant MeSH terms:
|
Ascites Fatigue Hepatic Encephalopathy Liver Cirrhosis Fibrosis Pathologic Processes Signs and Symptoms Liver Failure |
Hepatic Insufficiency Liver Diseases Digestive System Diseases Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases Nervous System Diseases Metabolic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013