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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01777971
First received: January 24, 2013
Last updated: October 2, 2014
Last verified: October 2014
  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
Ascites
Fatigue
Procedure: Large Volume Paracentesis
Behavioral: Fatigue Impact Scale
Behavioral: 6 Minute Walk Test

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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Fatigue [ Time Frame: 10 min ] [ Designated as safety issue: No ]
    Patients undergo 6-minute walk test and fill out Fisk Impact Scale (Fatigue Questionnaire)


Secondary Outcome Measures:
  • 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: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fatigue
The Fatigue Impact Scale questionnaire and 6-minute walk test will be administered to subjects in this arm.
Procedure: Large Volume Paracentesis
procedure done to remove large volume of ascitic fluid that has collected in the peritoneum.
Behavioral: Fatigue Impact Scale
The Fatigue Impact Scale will be administered to assess levels of fatigue.
Behavioral: 6 Minute Walk Test
The 6 Minute Walk Test will be used to evaluate fatigue, by asking the subjects to walk continually for 6 minutes and recording the distance walked in that time period.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777971

Contacts
Contact: Samuel Sigal, MD 212-263-0102 samuel.sigal@nyumc.edu

Locations
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         
Sponsors and Collaborators
New York University School of Medicine
Investigators
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: October 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fatigue
Hepatic Encephalopathy
Liver Cirrhosis
Brain Diseases
Brain Diseases, Metabolic
Central Nervous System Diseases
Digestive System Diseases
Hepatic Insufficiency
Liver Diseases
Liver Failure
Metabolic Diseases
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014