Heart Failure and Peritoneal Ultrafiltration

This study has been terminated.
(Enrollment)
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00368641
First received: August 23, 2006
Last updated: April 30, 2009
Last verified: April 2009

August 23, 2006
April 30, 2009
August 2006
April 2008   (final data collection date for primary outcome measure)
All-Cause Hospitalization (Unadjusted) [ Time Frame: 6 to 24 months ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00368641 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Heart Failure and Peritoneal Ultrafiltration
Treatment-Resistant Heart Failure (HF) and Peritoneal Ultrafiltration (PUF): A Randomized Prospective Trial of Standard Care Versus Standard Care With Peritoneal Ultrafiltration in Patients With Treatment-Resistant Severe Heart Failure

The objective of the study is to determine if the addition of peritoneal ultrafiltration to standard therapy in treatment-resistant severe heart failure patients will improve fluid balance and functional capacity such that they will spend less time in the hospital and have an improved ambulatory quality of life in comparison to patients who remain on standard therapy alone.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Congestive Heart Failure
Drug: Extraneal
Periotneal Dialysis
  • Experimental: Intervention
    peritoneal dialysis
    Intervention: Drug: Extraneal
  • No Intervention: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults with congestive heart failure (CHF) who remain fluid overloaded despite standard treatment.

Exclusion Criteria:

  • Patients who have reversible CHF or have diseases or conditions that would contraindicate the use of peritoneal dialysis.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada
 
NCT00368641
25885
No
Bruce Culleton, Sr. Medical Director, Baxter Healthcare Corporation
Baxter Healthcare Corporation
Not Provided
Study Chair: Baxter Healthcare Corporation Baxter Healthcare Corporation
Baxter Healthcare Corporation
April 2009

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