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. Identifier: NCT00368641
Recruitment Status : Terminated (Enrollment)
First Posted : August 25, 2006
Results First Posted : June 17, 2009
Last Update Posted : May 22, 2017
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Congestive Heart Failure
Intervention: Drug: Extraneal

  Participant Flow

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
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] 
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      2  33.3%      2  16.7% 
>=65 years      6 100.0%      4  66.7%      10  83.3% 
[Units: Years]
Mean (Standard Deviation)
 77.8  (4.1)   70.7  (13.1)   74.3  (10.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      1  16.7%      1  16.7%      2  16.7% 
Male      5  83.3%      5  83.3%      10  83.3% 
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

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

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

Responsible Party: Baxter Healthcare Corporation Identifier: NCT00368641     History of Changes
Other Study ID Numbers: 25885
First Submitted: August 23, 2006
First Posted: August 25, 2006
Results First Submitted: April 30, 2009
Results First Posted: June 17, 2009
Last Update Posted: May 22, 2017