AscitesNCT00603200
Effect of Large Volume Paracentesis on Fatigue in Cirrhosis
An observational study of Ascites and Fatigue, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purposeof this study is to determine the effect of a large volume paracentesis (procedure in whihc a catheter is placed to remove fluid from the abdomen) on the severity of fatigue i patients with cirrhosis (severe scarring of the liver) and large volume ascites (fluid in the abdomen). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cirrhosis and refractory ascites.
Who may be able to join
- ambulatory patient with cirrhosis
- baseline Cr <2
- ability to complete psychometric testing
- refractory ascites
Who cannot join
- Cr >2
- history of Gastrointestinal bleed
- history of infection
- history of renal failure
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterial, Weill Cornell medical College
New York, New York, 10021
About this study
Official title: The Effect of Large Volume Paracentesis on Fatigue in Cirrhosis
The purposeof this study is to determine the effect of a large volume paracentesis (procedure in whihc a catheter is placed to remove fluid from the abdomen) on the severity of fatigue i patients with cirrhosis (severe scarring of the liver) and large volume ascites (fluid in the abdomen).
- Keywords
- Quality of Life
- Medical subject headings
- Ascites, Fatigue, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with cirrhosis, who have refractory ascites requiring large volume paracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Fatigue symptomatology, as defined by fatigue questionnairre
Measured: instantly
Secondary outcomes (1)
Improvement in sleep
Measured: post paracentesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: Principal Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samual Sigal, MD, Principal investigator, Weill Medical College of Cornell UniversityReem Sharaiha, MD, Study director, New York Hospital-Cornell/Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603200
- Sponsor's protocol ID
- 0701008974
- Status last verified
- Dec 2023
- First submitted
- 15 Jan 2008
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Large Volume Paracentesis on Fatigue in Cirrhosis
- ClinicalTrials.gov ID
- NCT00603200
- Acronym / sponsor ID
- 0701008974
- Keywords
- Quality of Life
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposeof this study is to determine the effect of a large volume paracentesis (procedure in whihc a catheter is placed to remove fluid from the abdomen) on the severity of fatigue i patients with cirrhosis (severe scarring of the liver) and large volume ascites (fluid in the abdomen).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients with cirrhosis, who have refractory ascites requiring large volume paracentesis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cirrhosis and refractory ascites.
Key inclusion criteria (4 listed)
- ambulatory patient with cirrhosis
- baseline Cr <2
- ability to complete psychometric testing
- refractory ascites
Key exclusion criteria (4 listed)
- Cr >2
- history of Gastrointestinal bleed
- history of infection
- history of renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvement in Fatigue symptomatology, as defined by fatigue questionnairre
Time frame: instantly
1 secondary outcome
Improvement in sleep
Time frame: post paracentesis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samual Sigal, MD principal investigator
Weill Medical College of Cornell University
Reem Sharaiha, MD study director
New York Hospital-Cornell/Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ascites and Fatigue, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Fatigue symptomatology, as defined by fatigue questionnairre (time frame: instantly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.