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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Congestive Heart Failure Drug: Extraneal Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2006
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Icodextrin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention
peritoneal dialysis
Drug: Extraneal
Periotneal Dialysis
No Intervention: Standard of Care


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00368641     History of Changes
Other Study ID Numbers: 25885
First Posted: August 25, 2006    Key Record Dates
Results First Posted: June 17, 2009
Last Update Posted: May 22, 2017
Last Verified: April 2009

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Icodextrin
Dialysis Solutions
Pharmaceutical Solutions