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Heart Failure and Peritoneal Ultrafiltration

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.
ClinicalTrials.gov Identifier: NCT00368641
Recruitment Status : Terminated (Enrollment)
First Posted : August 25, 2006
Results First Posted : June 17, 2009
Last Update Posted : May 22, 2017
Information provided by (Responsible Party):

August 23, 2006
August 25, 2006
April 30, 2009
June 17, 2009
May 22, 2017
August 2006
April 2008   (Final data collection date for primary outcome measure)
All-cause Hospitalization (Unadjusted) [ Time Frame: 6 to 24 months ]
All-cause hospitalization was defined as (1) hospitalization for any cause of any duration or (2)any ER visit or any clinic visit specifically for congestive heart failure requiring intravenous administration of an inotrope, vasodilator or diuretic.
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Complete list of historical versions of study NCT00368641 on ClinicalTrials.gov Archive Site
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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.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Congestive Heart Failure
Drug: Extraneal
Periotneal Dialysis
  • Experimental: Intervention
    peritoneal dialysis
    Intervention: Drug: Extraneal
  • No Intervention: Standard of Care
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   United States
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Baxter Healthcare Corporation
Baxter Healthcare Corporation
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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