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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
Results First Received: April 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Congestive Heart Failure
Intervention: Drug: Extraneal

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
12 sites were active to enroll subjects from March 2, 2007 through February 29, 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were required to meet all inclusion and no exclusion criteria for study participation

Reporting Groups
  Description
Intervention Group Addition of peritoneal ultrafiltration
Standard Therapy Standard therapy for CHF

Participant Flow:   Overall Study
    Intervention Group     Standard Therapy  
STARTED     6     6  
COMPLETED     0 [1]   0 [1]
NOT COMPLETED     6     6  
Adverse Event                 2                 1  
Death                 1                 0  
Withdrawal by Subject                 1                 0  
Sponsor decision to terminate study                 2                 5  
[1] study was terminated prior to completion of treatment period



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention Group Addition of peritoneal ultrafiltration
Standard Therapy Standard therapy for CHF
Total Total of all reporting groups

Baseline Measures
    Intervention Group     Standard Therapy     Total  
Number of Participants  
[units: participants]
  6     6     12  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     2     2  
>=65 years     6     4     10  
Age  
[units: years]
Mean ± Standard Deviation
  77.8  ± 4.1     70.7  ± 13.1     74.3  ± 10.0  
Gender  
[units: participants]
     
Female     1     1     2  
Male     5     5     10  
Region of Enrollment  
[units: participants]
     
United States     2     2     4  
Canada     3     3     6  
Belgium     1     1     2  



  Outcome Measures

1.  Primary:   All-cause Hospitalization (Unadjusted)   [ Time Frame: 6 to 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The number of subjects enrolled & duration of therapy were insufficient to complete the planned efficacy analyses & to draw any conclusion regarding all-cause hospitalization rates in both intervention and standard therapy arms.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Bruce Culleton, MD
Organization: Baxter Healthcare
phone: 800-422-9837
e-mail: onebaxter@baxter.com


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