Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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):
Baxter Healthcare Corporation

Tracking Information
First Submitted Date  ICMJE August 23, 2006
First Posted Date  ICMJE August 25, 2006
Results First Submitted Date  ICMJE April 30, 2009
Results First Posted Date  ICMJE June 17, 2009
Last Update Posted Date May 22, 2017
Study Start Date  ICMJE August 2006
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00368641 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart Failure and Peritoneal Ultrafiltration
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Congestive Heart Failure
Intervention  ICMJE Drug: Extraneal
Periotneal Dialysis
Study Arms  ICMJE
  • Experimental: Intervention
    peritoneal dialysis
    Intervention: Drug: Extraneal
  • No Intervention: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 18, 2008)
12
Original Enrollment  ICMJE
 (submitted: August 23, 2006)
104
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00368641
Other Study ID Numbers  ICMJE 25885
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baxter Healthcare Corporation
Study Sponsor  ICMJE Baxter Healthcare Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Baxter Healthcare Corporation Baxter Healthcare Corporation
PRS Account Baxter Healthcare Corporation
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP