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Effect of Large Volume Paracentesis on Fatigue in Cirrhosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00603200
First received: January 15, 2008
Last updated: November 4, 2010
Last verified: November 2010
History of Changes
  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:

MedlinePlus related topics: Cirrhosis Fatigue
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in sleep [ Time Frame: post paracentesis ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Samual Sigal, Department of Gastroentorology and Hepatology.
ClinicalTrials.gov Identifier: NCT00603200     History of Changes
Other Study ID Numbers: 0701008974
Study First Received: January 15, 2008
Last Updated: November 4, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013