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Heart Failure and Peritoneal Ultrafiltration

This study has been terminated.
(Enrollment)
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00368641
First received: August 23, 2006
Last updated: April 19, 2017
Last verified: April 2009
August 23, 2006
April 19, 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.
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
Intervention Model: Parallel Assignment
Masking: No masking
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   United States
 
 
NCT00368641
25885
No
Not Provided
Not Provided
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