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
  Purpose

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.


Condition Intervention Phase
Congestive Heart Failure
Drug: Extraneal
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • All-Cause Hospitalization (Unadjusted) [ Time Frame: 6 to 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: August 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
peritoneal dialysis
Drug: Extraneal
Periotneal Dialysis
No Intervention: Standard of Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368641

Locations
United States, California
San Jose, California, United States
Torrance, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Illinois
Evanston, Illinois, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
Australia, Victoria
Melbourne, Victoria, Australia
Belgium
Leuven, Belgium
Liege, Belgium
Roeselare, Belgium
Canada, Ontario
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Chair: Baxter Healthcare Corporation Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Bruce Culleton, Sr. Medical Director, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00368641     History of Changes
Other Study ID Numbers: 25885
Study First Received: August 23, 2006
Results First Received: April 30, 2009
Last Updated: April 30, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Icodextrin
Dialysis Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014