A Phase 4 interventional study of IV loop diuretic and NxStage System One in Heart Failure and CHF, sponsored by NxStage Medical. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-19.
Sponsored by NxStage Medical · Phase 4, Interventional, and Treatment
The purpose of this study is to assess the ability of Ultrafiltration to influence the rate of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion pressure, in patients with NYHA class III/IV Heart Failure.
This study will be preformed in a specialized heart failure unit at the Cleveland Clinic Foundation (CCF) and will include both the UF-treated group and a control group receiving usual and customary care. Patients will be stratified according to renal function at the time of admission. Therapies will be guided by specific hemodynamic criteria routinely used at the study institution.
5,801 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 36 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →NxStage Medical is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
Device: NxStage System One
Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
Drug: IV loop diuretic
Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.
Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
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)
Time to Discharge From the Heart Failure (HF) Unit, and Time to Discharge From the Hospital.
Time frame: Time from admission to endpoint achievement
Total Volume Removal During the Intervention Period
Time frame: Intervention start to end.
Volume Removal Rate.
Hours of therapy required to remove 1 liter of fluid normalized to body weight.
Time frame: Intervention start to end.
Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths
Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge.
Time frame: Hospital discharge to 90 days after discharge
| Milestone | Ultrafiltration | Usual & Customary Care |
|---|---|---|
| Started | 19 | 17 |
| Completed | 14 | 7 |
| Not completed | 5 | 10 |
| Withdrew: Death | 4 | 4 |
| Withdrew: Transplant | 0 | 3 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Severe aortic stenosis | 1 | 0 |
| hours | Ultrafiltration | Usual & Customary Care |
|---|---|---|
| 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. | 22.0 ± 4.2 | 34.8 ± 6.7 |
| Days | Ultrafiltration | Usual & Customary Care |
|---|---|---|
| Time to discharge from HF unit | 3.63 ± 2.11 | 3.56 ± 1.86 |
| Time to discharge from hospital | 6.98 ± 4.81 | 18.93 ± 18.9 |
| milliliters | Ultrafiltration | Usual & Customary Care |
|---|---|---|
| Total Volume Removal During the Intervention Period | 5215 ± 3406 | 2167 ± 2380 |
Hours of therapy required to remove 1 liter of fluid normalized to body weight.
| milliliters/hour/kilogram | Ultrafiltration | Usual & Customary Care |
|---|---|---|
| Volume Removal Rate. | 3.4 ± 2.6 | 0.7 ± 1.1 |
Number of patients experiencing at least one of the composite endpoint measures within 90 days of hospital discharge.
| participants | Ultrafiltration | Usual & Customary Care |
|---|---|---|
| Composite Endpoint of Hospital Readmissions, Emergency Department Visits, and Deaths | 12 | 10 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ultrafiltration | — | 4/19 (21.1%) | 19/19 (100%) |
| Usual & Customary Care | — | 4/17 (23.5%) | 17/17 (100%) |
| Event | Ultrafiltration | Usual & Customary Care |
|---|---|---|
| Death (Cardiac reason)Cardiac disorders | 3/19 | 4/17 |
| Death (Infection-related)Infections and infestations | 1/19 | 0/17 |
| Event | Ultrafiltration | Usual & Customary Care |
|---|---|---|
| OtherGeneral disorders | 10/19 | 7/17 |
| Worsening Heart FailureCardiac disorders | 2/19 | 6/17 |
| Worsening Renal FailureRenal and urinary disorders | 6/19 | 4/17 |
| NauseaGeneral disorders | 5/19 | 4/17 |
| Hypotensive EpisodeRenal and urinary disorders | 3/19 | 4/17 |
| ConstipationGastrointestinal disorders | 3/19 | 1/17 |
| InfectionInfections and infestations | 3/19 | 2/17 |
| Chest PainCardiac disorders | 2/19 | 0/17 |
| CrampingGeneral disorders | 2/19 | 0/17 |
| HeadacheGeneral disorders | 2/19 | 1/17 |
| Age Continuous(years) | Ultrafiltration | Usual & Customary Care | Total |
|---|---|---|---|
| Mean | 60 ± 9.1 | 59 ± 15.5 | 59.5 ± 12 |
| Sex: Female, Male(Participants) | Ultrafiltration | Usual & Customary Care | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 16 | 13 | 29 |
| Region of Enrollment(participants) | Ultrafiltration | Usual & Customary Care | Total |
|---|---|---|---|
| United States | 19 | 17 | 36 |
| Glomerular Filtration Rate (GFR)(Participants) | Ultrafiltration | Usual & Customary Care | Total |
|---|---|---|---|
| GFR >50 mL/min/1.73m2 | 9 | 10 | 19 |
| GFR <50 mL/min/1.73m2 | 10 | 7 | 17 |
The record gives a start of Oct 2003, a primary completion of Sep 2008 and a completion of Jan 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2012, 3 years 9 months after primary completion.
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This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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