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Effect of Large Volume Paracentesis on Fatigue in Cirrhosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Weill Medical College of Cornell University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00603200
First Posted: January 28, 2008
Last Update Posted: November 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Weill Medical College of Cornell University
  Purpose
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).

Condition
Ascites Fatigue Cirrhosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of Large Volume Paracentesis on Fatigue in Cirrhosis

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Improvement in Fatigue symptomatology, as defined by fatigue questionnairre [ Time Frame: instantly ]

Secondary Outcome Measures:
  • Improvement in sleep [ Time Frame: post paracentesis ]

Estimated Enrollment: 10
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Patients with cirrhosis, who have refractory ascites requiring large volume paracentesis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cirrhosis and refractory ascites.
Criteria

Inclusion Criteria:

  • ambulatory patient with cirrhosis
  • baseline Cr <2
  • ability to complete psychometric testing
  • refractory ascites

Exclusion Criteria:

  • Cr >2
  • history of Gastrointestinal bleed
  • history of infection
  • history of renal failure
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603200


Contacts
Contact: Samual Sigal, MD 6469625483
Contact: Reem Sharaiha, MD 212-305-2323 rzs2110@columbia.edu

Locations
United States, New York
New York Presbyterial, Weill Cornell medical College Recruiting
New York, New York, United States, 10021
Contact: Samual Sigal, Md    646-962-5483      
Contact: Reem Sharaiha, MD    12127465020      
Principal Investigator: Samual Sigal, MD         
Sub-Investigator: Reem Sharaiha, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Samual Sigal, MD Weill Medical College of Cornell University
Study Director: Reem Sharaiha, MD New York Hospital-Cornell/Columbia
  More Information

Responsible Party: Dr Samual Sigal, Department of Gastroentorology and Hepatology.
ClinicalTrials.gov Identifier: NCT00603200     History of Changes
Other Study ID Numbers: 0701008974
First Submitted: January 15, 2008
First Posted: January 28, 2008
Last Update Posted: November 5, 2010
Last Verified: November 2010

Keywords provided by Weill Medical College of Cornell University:
Quality of Life

Additional relevant MeSH terms:
Fatigue
Fibrosis
Liver Cirrhosis
Ascites
Signs and Symptoms
Pathologic Processes
Liver Diseases
Digestive System Diseases