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Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NxStage Medical
ClinicalTrials.gov Identifier:
NCT00288587
First received: February 6, 2006
Last updated: May 16, 2012
Last verified: May 2012
History of Changes
Results First Received: May 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Heart Failure
CHF
Interventions: Drug: IV loop diuretic
Device: NxStage System One

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ultrafiltration Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
Usual & Customary Care Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.

Participant Flow:   Overall Study
    Ultrafiltration     Usual & Customary Care  
STARTED     19     17  
COMPLETED     14     7  
NOT COMPLETED     5     10  
Death                 4                 4  
Transplant                 0                 3  
Adverse Event                 0                 1  
Physician Decision                 0                 2  
Severe Aortic Stenosis                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Ultrafiltration Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
Usual & Customary Care Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
Total Total of all reporting groups

Baseline Measures
    Ultrafiltration     Usual & Customary Care     Total  
Number of Participants  
[units: participants]
 		  19     17     36  
Age  
[units: years]
Mean ± Standard Deviation 		  60  ± 9.1     59  ± 15.5     59.5  ± 12  
Gender  
[units: participants]
 		     
Female     3     4     7  
Male     16     13     29  
Region of Enrollment  
[units: participants]
 		     
United States     19     17     36  
Glomerular Filtration Rate (GFR)  
[units: Participants]
 		     
GFR >50 mL/min/1.73m2     9     10     19  
GFR <50 mL/min/1.73m2     10     7     17  



  Outcome Measures
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1.  Primary:   Time Required for the Pulmonary Artery Occlusion Pressure (PAOP) to be Maintained at a Value of Less Than or Equal to 18 mmHg for at Least Four Consecutive Hours (+/- 30 Minutes) During the Intervention Period.   [ Time Frame: 4 consecutive hours (+/- 30 minutes) ]
  Show Outcome Measure 1

2.  Secondary:   Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.   [ Time Frame: Time from admission to endpoint achievement ]
  Show Outcome Measure 2

3.  Secondary:   Total Volume Removal During the Intervention Period   [ Time Frame: Intervention start to end. ]
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4.  Secondary:   Volume Removal Rate.   [ Time Frame: Intervention start to end. ]
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5.  Secondary:   Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths   [ Time Frame: Hospital discharge to 90 days after discharge ]
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  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Ultrafiltration Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
Usual & Customary Care Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.

Other Adverse Events
    Ultrafiltration     Usual & Customary Care  
Total, other (not including serious) adverse events      
# participants affected / at risk     19/19     17/17  
Cardiac disorders      
Arrhythmia *    
# participants affected / at risk     1/19 (5.26%)     1/17 (5.88%)  
# events     1     3  
Chest Pain *    
# participants affected / at risk     2/19 (10.53%)     0/17 (0.00%)  
# events     2     0  
Brady Arrhythmia *    
# participants affected / at risk     0/19 (0.00%)     1/17 (5.88%)  
# events     0     2  
Worsening Heart Failure *    
# participants affected / at risk     2/19 (10.53%)     6/17 (35.29%)  
# events     2     7  
Endocrine disorders      
Hypoglycemic Episode *    
# participants affected / at risk     1/19 (5.26%)     0/17 (0.00%)  
# events     1     0  
Gastrointestinal disorders      
Constipation *    
# participants affected / at risk     3/19 (15.79%)     1/17 (5.88%)  
# events     3     1  
Diarrhea *    
# participants affected / at risk     0/19 (0.00%)     1/17 (5.88%)  
# events     0     1  
General disorders      
Cramping *    
# participants affected / at risk     2/19 (10.53%)     0/17 (0.00%)  
# events     2     0  
Fever > 37.3 C *    
# participants affected / at risk     0/19 (0.00%)     1/17 (5.88%)  
# events     0     1  
Headache *    
# participants affected / at risk     2/19 (10.53%)     1/17 (5.88%)  
# events     2     1  
Insomnia *    
# participants affected / at risk     2/19 (10.53%)     0/17 (0.00%)  
# events     2     0  
Nausea *    
# participants affected / at risk     5/19 (26.32%)     4/17 (23.53%)  
# events     5     4  
Other *    
# participants affected / at risk     10/19 (52.63%)     7/17 (41.18%)  
# events     18     11  
Infections and infestations      
Infection *    
# participants affected / at risk     3/19 (15.79%)     2/17 (11.76%)  
# events     3     2  
Renal and urinary disorders      
Hypotensive Episode *    
# participants affected / at risk     3/19 (15.79%)     4/17 (23.53%)  
# events     3     4  
Worsening Renal Failure *    
# participants affected / at risk     6/19 (31.58%)     4/17 (23.53%)  
# events     6     4  
Vascular disorders      
Claudication *    
# participants affected / at risk     1/19 (5.26%)     0/17 (0.00%)  
# events     1     0  
Painful Access *    
# participants affected / at risk     0/19 (0.00%)     1/17 (5.88%)  
# events     0     1  
* Events were collected by non-systematic assessment



  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.


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
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Results Point of Contact:  
Name/Title: Leighann Cesar, RN
Organization: Cleveland Clinic Foundation
phone: 216-445-6551
e-mail: cesar1@ccf.org


Publications of Results:


Responsible Party: NxStage Medical
ClinicalTrials.gov Identifier: NCT00288587     History of Changes
Other Study ID Numbers: CP0007
Study First Received: February 6, 2006
Results First Received: May 16, 2012
Last Updated: May 16, 2012
Health Authority: United States: Institutional Review Board