The Effect of a Large-volume Paracentesis on Fatigue, Sleep, and Quality of Life in Cirrhosis
Public ClinicalTrials.gov record NCT01777971. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01777971
- Recruitment status
- Withdrawn
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- Not listed
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2012
- Primary completion
- Sep 30, 2014
- Completion
- Sep 30, 2014
- Last update posted
- Aug 3, 2015
2012 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01777971, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 3, 2015 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01777971 live on ClinicalTrials.gov.