Heart Failure and Peritoneal Ultrafiltration
This study has been terminated.
(Enrollment)
Sponsor:
Baxter Healthcare Corporation
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00368641
First received: August 23, 2006
Last updated: April 30, 2009
Last verified: April 2009
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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
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 |
ClinicalTrials.gov processed this record on May 23, 2013