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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
January 15, 2008
January 28, 2008
November 5, 2010
January 2008
June 2008   (Final data collection date for primary outcome measure)
Improvement in Fatigue symptomatology, as defined by fatigue questionnairre [ Time Frame: instantly ]
Same as current
Complete list of historical versions of study NCT00603200 on ClinicalTrials.gov Archive Site
Improvement in sleep [ Time Frame: post paracentesis ]
Same as current
Not Provided
Not Provided
 
Effect of Large Volume Paracentesis on Fatigue in Cirrhosis
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).
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with cirrhosis and refractory ascites.
  • Ascites
  • Fatigue
  • Cirrhosis
Not Provided
Group 1
Patients with cirrhosis, who have refractory ascites requiring large volume paracentesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
10
December 2009
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00603200
0701008974
No
Not Provided
Not Provided
Dr Samual Sigal, Department of Gastroentorology and Hepatology.
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Samual Sigal, MD Weill Medical College of Cornell University
Study Director: Reem Sharaiha, MD New York Hospital-Cornell/Columbia
Weill Medical College of Cornell University
November 2010