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

January 15, 2008
November 4, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00603200 on ClinicalTrials.gov Archive Site
Improvement in sleep [ Time Frame: post paracentesis ] [ Designated as safety issue: No ]
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.
 
Recruiting
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
Both
18 Years to 70 Years
No
Contact: Samual Sigal, MD 6469625483
Contact: Reem Sharaiha, MD 212-305-2323 rzs2110@columbia.edu
United States
 
NCT00603200
0701008974
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP