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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00288587 |
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Date of registration:
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06/02/2006 |
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Primary sponsor: |
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Public title:
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Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)
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Scientific title:
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CP0007: Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF) |
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Date of first enrolment:
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October 2003 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00288587 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Alan Hull, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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NxStage Medical |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Admitted to Heart Failure Unit (H-22) with NYHA class III/IV HF and pulmonary artery
catheter in situ
- Left ventricular ejection fraction <40%
- Mean Pulmonary Artery Occlusion Pressure =20 mm Hg
- Able to give informed consent
Exclusion Criteria:
- Currently on renal replacement therapy or determined to need renal replacement
therapy at the time of enrollment
- Estimated glomerular filtration rate (GFR) <15 mL/min
- Systolic blood pressure (SBP) <80 mm Hg
- Acute coronary syndrome
- Hematocrit >50%
- Malignancy other than prostrate or skin
- Chronic edematous states other than HF, including nephritic syndrome and cirrhosis
- Chronic inflammatory or infectious condition
- Pregnancy
- Previous enrollment in this study
- Expectation of need for heart transplantation or cardiac assist device within one
week
- Pulmonary failure requiring intubation and mechanical ventilation
- Known or suspected hypersensitivity to dialysis membranes
- Severe aortic stenosis or regurgitation
- Severe mitral stenosis
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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CHF
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Heart Failure
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Intervention(s)
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Device: NxStage System One
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Drug: IV loop diuretic
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Primary Outcome(s)
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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)]
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Secondary Outcome(s)
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Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths
[Time Frame: Hospital discharge to 90 days after discharge]
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Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.
[Time Frame: Time from admission to endpoint achievement]
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Total Volume Removal During the Intervention Period
[Time Frame: Intervention start to end.]
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Volume Removal Rate.
[Time Frame: Intervention start to end.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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