120 Participants NeededMy employer runs this trial

Ultrafiltration for Kidney Failure

(DRIVE-UF Trial)

LR
EA
Overseen ByErnest Ayers, MSPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
Must be taking: Anti-hypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether extra ultrafiltration treatments can help dialysis patients by removing excess fluid from their bodies. The goal is to determine if reducing this fluid improves symptoms and blood pressure. Ultrafiltration, a type of dialysis, focuses on fluid removal without blood cleaning. Participants will either continue with regular dialysis or receive additional ultrafiltration for 4 or 8 weeks. Ideal candidates are those currently on dialysis for kidney disease who have high blood pressure despite multiple medications or experience symptoms of fluid overload. As an unphased trial, this study offers an opportunity to explore new methods for improving health and managing symptoms.

What prior data suggests that ultrafiltration is safe for kidney failure patients?

Research has shown that ultrafiltration, a dialysis method for removing excess fluid, can pose safety concerns. Faster ultrafiltration rates, which refer to how quickly fluid is removed, are linked to higher health risks, including increased mortality, particularly for patients who regularly undergo hemodialysis. Studies have found that rates exceeding 10-13 mL/kg/h lead to more heart-related problems and lower survival rates.

Despite these concerns, ultrafiltration is often considered a gentler form of dialysis compared to standard methods. It focuses on fluid removal without blood cleansing, potentially reducing strain on the body. While potential risks exist, effects can vary based on individual health and specific rates used. Prospective clinical trial participants should consult their healthcare provider to understand the implications for their health.12345

Why are researchers excited about this trial?

Researchers are excited about ultrafiltration for kidney failure because it offers a unique approach compared to standard hemodialysis, which is typically performed thrice weekly. Ultrafiltration specifically targets excess fluid removal without the extensive filtering of blood, potentially leading to better fluid management and blood pressure control. This trial is exploring ultrafiltration combined with the careful tapering of blood pressure medications, which may enhance patient outcomes by reducing the strain on the heart and kidneys more effectively than traditional methods alone. The two different durations being tested—4 weeks and 8 weeks—could reveal optimal treatment lengths for maximizing benefits and minimizing side effects.

What evidence suggests that ultrafiltration might be an effective treatment for kidney failure?

Research has shown that ultrafiltration effectively removes extra fluid in patients with kidney failure. Unlike traditional dialysis, which also cleans the blood, this method focuses solely on fluid removal. In this trial, some participants will receive ultrafiltration treatments for up to 4 weeks, while others will receive them for up to 8 weeks. Studies have found that eliminating excess fluid with ultrafiltration can better control blood pressure and reduce stress on the heart and lungs. By targeting fluid buildup, ultrafiltration may lessen symptoms and reduce hospital visits for those on dialysis. Early findings suggest it could offer a gentler way to manage fluid-related issues in kidney disease, with lasting benefits.678910

Who Is on the Research Team?

BK

Bryan Kestenbaum, MD, MS

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for people with kidney failure who are on hemodialysis and have problems with extra fluid in their body, such as swelling or high blood pressure. Participants should be able to safely undergo additional fluid removal sessions.

Inclusion Criteria

I have high blood pressure before dialysis, possibly due to extra fluid in my body.
I have symptoms of fluid buildup and a KM-KCCQ score below 75.
I have been getting in-center hemodialysis three times a week for at least four weeks.

Exclusion Criteria

I am currently on or planning to start intensive hemodialysis (4+ times per week).
I have not had a major heart or bleeding event in the last 90 days.
I am currently receiving chemotherapy or radiation for cancer.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a four-week or eight-week ultrafiltration strategy, or continue regular hemodialysis treatments

4-8 weeks
2 extra visits per week for ultrafiltration

Follow-up

Participants are monitored for changes in blood pressure and symptoms of congestion

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ultrafiltration

Trial Overview

The study tests whether doing extra ultrafiltration treatments over 4 or 8 weeks can remove more excess fluid than usual care, aiming to improve blood pressure and reduce symptoms related to too much fluid.

How Is the Trial Designed?

3

Treatment groups

Active Control

Group I: Control armActive Control1 Intervention
Group II: Ultrafiltration treatments for up to 4 weeksActive Control1 Intervention
Group III: Ultrafiltration treatments for up to 8 weeksActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Epidemiology of acute renal failure: a prospective ...

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Bouman et al. reported no increase in survival among 106 patients in a comparison of prescribed effluent flows of 48 and 20 ml per kilogram per ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29402814/

Association of Ultrafiltration Rate with Mortality in Incident ...

Conclusions: Higher UFR is independently associated with higher all-cause and CV mortality in incident HD patients. Clinical trials are ...

Ultrafiltration Rate, Residual Kidney Function, and Survival ...

Higher UFR was associated with worse outcomes, including shorter survival and more rapid loss of RKF, among patients receiving regular HD treatments

Ultrafiltration Rate Effects Declines in Residual Kidney ...

Several large-scale studies have shown that high UF rates, typically exceeding 10-13 mL/kg/h, are associated with adverse CV outcomes and increased mortality

Ultrafiltration Rate Thresholds in Maintenance Hemodialysis

High hemodialysis ultrafiltration rate (UFR) is increasingly recognized as an important and modifiable risk factor for mortality among ...