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| Name | Class |
|---|---|
| Vizio Medical Devices | UNKNOWN |
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In this study, the researchers want to find out how patients who have ultrafiltration (removal of excess fluid) 6 times a week and twice-weekly dialysis (removal of excess fluid and waste products) do in terms of their blood pressure and weight. The researchers believe that maintaining patients at their estimated target weight throughout the week using daily ultrafiltration will reduce their blood pressure to levels shown in other similar studies. Such a reduction in blood pressure may reduce the incidence of cerebral vascular disease, peripheral vascular disease, coronary artery disease, and congestive heart failure. The researchers also believe that patients' quality of life will improve while they are undergoing daily ultrafiltration.
Studies show that more frequent dialysis treatments result in fewer symptoms for patients. The patients feel better and avoid the weight gains and symptoms that patients have on three times a week dialysis. In addition, their blood lab results are better controlled, requiring less medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily ultrafiltration | Experimental | During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrafiltration | Procedure | Frequency of ultrafiltration is increased from the conventional 3 times a week to 6 times a week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Blood Pressure | Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan W Levin, MD | Renal Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irving Place Dialysis Center | New York | New York | 10003 | United States | ||
| Upper Manhattan Dialysis Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3727139 | Result | Bytzer P. [Laxative abuse]. Ugeskr Laeger. 1986 Jun 2;148(23):1387-9. No abstract available. Danish. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daily Ultrafiltration | During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Daily Ultrafiltration | During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Arterial Blood Pressure | Posted | Mean | Full Range | mm Hg | Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prestudy Phase | During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Jones, MD | St. Luke's-Roosevelt Hospital Center | 2125233530 | JaJones@chpnet.org |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D014462 | Ultrafiltration |
| ID | Term |
|---|---|
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D005374 | Filtration |
| D002623 | Chemistry Techniques, Analytical |
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| New York |
| New York |
| 10025 |
| United States |
| Yorkville Dialysis Center | New York | New York | 10128 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.
|
|
| 0 |
| 0 |
| 0 |
| 13 |
| EG001 | Daily Ultrafiltration Phase | During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week. | 2 | 13 | 0 | 13 |
| EG002 | Return Phase | During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments. | 1 | 13 | 0 | 13 |
| Elevated Potassium | Metabolism and nutrition disorders |
|
| Elevated Glucose Level | Metabolism and nutrition disorders |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |
| D055585 | Physical Phenomena |
| D055598 | Chemical Phenomena |