An interventional study of Ultrafiltration in End-stage Renal Disease, sponsored by Renal Research Institute. Completed at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-05-26.
Sponsored by Renal Research Institute · Not applicable, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 13 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Renal Research Institute is the lead sponsor of 18 studies on the registry; none are open to participants now.
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Exclusion Criteria:
During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
Procedure: Ultrafiltration
Frequency of ultrafiltration is increased from the conventional 3 times a week to 6 times a week.
Mean Arterial Blood Pressure
Time frame: Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)
| Milestone | Daily Ultrafiltration |
|---|---|
| Started | 13 |
| Completed | 12 |
| Not completed | 1 |
| mm Hg | Prestudy Phase | Daily Ultrafiltration Phase | Return Phase |
|---|---|---|---|
| Mean Arterial Blood Pressure | 110 (84 to 133) | 95 (84 to 111) | 106 (92 to 121) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prestudy Phase | — | — | 0/13 (0%) |
| Daily Ultrafiltration Phase | — | 2/13 (15.4%) | 0/13 (0%) |
| Return Phase | — | 1/13 (7.7%) | 0/13 (0%) |
| Event | Prestudy Phase | Daily Ultrafiltration Phase | Return Phase |
|---|---|---|---|
| InfectionInfections and infestations | — | 1/13 | 0/13 |
| Elevated PotassiumMetabolism and nutrition disorders | — | 0/13 | 1/13 |
| Elevated Glucose LevelMetabolism and nutrition disorders | — | 1/13 | 0/13 |
| Age, Categorical(Participants) | Daily Ultrafiltration |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 0 |
| Age, Continuous(years) | Daily Ultrafiltration |
|---|---|
| Mean | 50.6 ± 8.23 |
| Sex: Female, Male(Participants) | Daily Ultrafiltration |
|---|---|
| Female | 6 |
| Male | 7 |
| Region of Enrollment(participants) | Daily Ultrafiltration |
|---|---|
| United States | 13 |
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Renal Research Institute