Back to resultsHeart Failure and Peritoneal Ultrafiltration
Primary Purpose
Congestive Heart Failure
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Extraneal
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Standard of Care
Arm Description
peritoneal dialysis
Outcomes
Primary Outcome Measures
All-cause Hospitalization (Unadjusted)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00368641
First Posted
August 23, 2006
Last Updated
April 19, 2017
Sponsor
Baxter Healthcare Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00368641
Brief Title
Heart Failure and Peritoneal Ultrafiltration
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 Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Why Stopped
Enrollment
Study Start Date
August 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
peritoneal dialysis
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Extraneal
Intervention Description
Periotneal Dialysis
Primary Outcome Measure Information:
Title
All-cause Hospitalization (Unadjusted)
Description
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.
Time Frame
6 to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baxter Healthcare Corporation
Organizational Affiliation
Baxter Healthcare Corporation
Official's Role
Study Chair
Facility Information:
City
San Jose
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Evanston
State/Province
Illinois
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Melbourne
State/Province
Victoria
Country
Australia
City
Leuven
Country
Belgium
City
Liege
Country
Belgium
City
Roeselare
Country
Belgium
City
Toronto
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Heart Failure and Peritoneal Ultrafiltration
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