IBPS-Guided Ultrafiltration for Kidney Failure

Overseen By Peter N Van Buren, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Clonidine, Midodrine

Disqualifiers: Pregnancy, Blood pressure extremes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

69 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve kidney failure treatment in Veterans undergoing hemodialysis. It tests a new method, IBPS-Guided Ultrafiltration, which removes excess fluid during dialysis by adjusting based on recent blood pressure patterns. The trial compares this method to standard care, focusing on its impact on blood pressure changes and its ability to reduce dangerously low blood pressure during treatment. Hemodialysis patients with consistently high blood pressure before or after treatments may be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance dialysis care for Veterans.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who routinely use certain blood pressure medications during dialysis. It's best to discuss your specific medications with the trial team.

What prior data suggests that IBPS-Guided Ultrafiltration is safe for kidney failure patients?

Research has shown that IBPS-Guided Ultrafiltration is being studied to help control fluid levels in individuals receiving dialysis for kidney failure. The primary goal is to prevent fluid overload while maintaining stable blood pressure during treatment.

In terms of safety, past patients have shown that using blood pressure changes during dialysis to guide treatment can effectively manage fluid levels. This method has been safely applied in other contexts, such as with heart failure patients, to monitor heart activity and fluid balance.

While specific safety data for IBPS-Guided Ultrafiltration is limited, the approach is based on methods already used successfully in similar patient groups. Available research has not reported major negative effects from using blood pressure changes to guide dialysis treatment. Prospective trial participants should discuss any concerns with the study team for more personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about IBPS-Guided Ultrafiltration for kidney failure because it introduces a novel approach to managing fluid removal during dialysis. Unlike traditional methods that rely solely on a nephrologist's judgment, this technique uses intradialytic blood pressure slopes (IBPS) to adjust fluid removal targets. This personalized, data-driven method has the potential to prevent complications like low blood pressure, which can happen during standard dialysis treatments. By tailoring the ultrafiltration process to each patient's blood pressure trends, this method aims to improve patient outcomes and comfort.

What evidence suggests that IBPS-Guided Ultrafiltration is effective for kidney failure?

Research has shown that using the Intradialytic Blood Pressure Slope (IBPS) to guide fluid removal during dialysis benefits patients, particularly those with unstable blood pressure. In this trial, the study investigator will adjust the target weight of participants in the IBPS Arm each month based on recent assessments of intradialytic blood pressure slopes. Patients with lower IBPS tend to maintain more stable blood pressure during treatment. This method effectively manages blood pressure and fluid levels, which are crucial for dialysis patients. Studies suggest this approach could reduce the risk of dangerously low blood pressure during dialysis. By adjusting the target weight based on recent blood pressure patterns, IBPS-guided fluid removal aims to improve patient outcomes. ^{1 2 3 4 5}

Who Is on the Research Team?

Peter Noel Van Buren, MD

Principal Investigator

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Are You a Good Fit for This Trial?

This trial is for Veterans with kidney failure who are on hemodialysis and have high blood pressure before or after treatments. They must not be pregnant, have a pacemaker, metallic implants, or severe low blood pressure issues. Also excluded are those new to dialysis, using certain blood pressure medications during dialysis, or non-adherent to antihypertensive meds.

Inclusion Criteria

I am on hemodialysis.

My average blood pressure before or after dialysis is above the normal range.

Exclusion Criteria

Your blood pressure before or after dialysis is consistently higher than 180 mmHg.

I have not consistently taken my blood pressure medication as prescribed.

I have been on hemodialysis for less than 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard care or an IBPS-based ultrafiltration prescription, with monthly adjustments based on recent intradialytic blood pressure slopes

4 months

Monthly visits for ultrafiltration prescription adjustments

Follow-up

Participants are monitored for changes in ambulatory systolic blood pressure and other secondary outcomes

4 months

What Are the Treatments Tested in This Trial?

Interventions

• IBPS-Guided Ultrafiltration

Trial Overview The study tests a new method of removing fluid during dialysis based on patients' recent blood pressure trends compared to standard care. It aims to see if this can manage overall blood pressure better and reduce dangerous drops in blood pressure that occur during the treatment process.

How Is the Trial Designed?

Group I: IBPS (Intradialytic Blood Pressure Slope) Arm Experimental Treatment 1 Intervention

IBPS participants will have their target weight adjusted each month by the study investigator based on recent assessment of intradialytic blood pressure slopes.

Group II: Control Active Control 1 Intervention

Participants in the control group will have their blood pressure, fluid status, as well as all other aspects of clinical care managed in entirety by their treating nephrologists.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study of 40 hemodialysis patients, additional volume reduction through ultrafiltration significantly improved blood pressure in patients with intradialytic hypertension (IDH) who had high predialytic blood pressure, showing a decrease in systolic blood pressure by 12.09 mmHg after treatment.

Conversely, patients with normal predialytic blood pressure did not experience any significant improvement in blood pressure despite similar treatment, indicating that the effectiveness of ultrafiltration may depend on the initial blood pressure status of the patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dry-weight reduction improves intradialytic hypertension only in patients with high predialytic blood pressure. Zhang, Y., Zhang, X., Li, J., et al.[2019]

Ultrafiltration failure (UFF) is a common complication in peritoneal dialysis, particularly increasing in frequency with longer treatment durations.

The review highlights that peritonitis and long-term peritoneal dialysis are the two main conditions leading to UFF, and it provides diagnostic and therapeutic strategies to address these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrafiltration failure in peritoneal dialysis. Causes and clinical consequences. Smit, W., Parikova, A., Krediet, RT.[2017]

Extracorporeal ultrafiltration (UF) is effective for short-term management of patients with congestive heart failure (CHF) who have severe fluid overload, leading to significant improvements in symptoms and quality of life.

Peritoneal dialysis (PD) may be more suitable for long-term treatment of CHF, but further research is needed to determine if these therapies can improve survival rates in patients with refractory CHF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of peritoneal dialysis in the management of treatment-resistant congestive heart failure: A European perspective. Khalifeh, N., Vychytil, A., Hörl, WH.[2019]

This study investigates the effects of ultrafiltration profiling, a method of adjusting fluid removal rates during hemodialysis, on cardiovascular complications in patients undergoing maintenance hemodialysis, aiming to reduce risks associated with rapid fluid removal.

The trial involves a randomized 4-phase cross-over design with participants alternating between conventional ultrafiltration and ultrafiltration profiling, assessing key outcomes like intradialytic hypotension and heart function over a total of 9 weeks, which may provide insights into safer hemodialysis practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrafiltration-profiled hemodialysis to reduce dialysis-related cardiovascular stress: Study protocol for a randomized controlled trial. Tugman, MJ., Narendra, JH., Li, Q., et al.[2021]

A systematic review of nine studies involving 1062 patients with acute renal failure found no significant survival advantage for patients using biocompatible membranes (BCM) compared to bioincompatible membranes (BICM) during intermittent hemodialysis.

The analysis also showed no significant difference in the recovery of renal function between the two types of membranes, indicating that BCM does not provide a clinical benefit over BICM in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biocompatible hemodialysis membranes for acute renal failure. Alonso, A., Lau, J., Jaber, BL.[2018]

In a study of 60 hemodialysis patients, higher ultrafiltration (UF) rates (≥5% of post-dialysis body weight) were linked to significant decreases in post-dialysis blood volume relative to pre-dialysis blood volume, indicating potential risks for patient outcomes.

The study found that the post-dialysis blood volume was influenced by the total ultrafiltration ratio, excess fluid mass, and microvascular filtration coefficients, suggesting that careful management of UF is crucial for maintaining optimal fluid balance in hemodialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does higher ultrafiltration within the conventional clinical range impact the volume status of hemodialysis patients? Yashiro, M., Kamata, T., Segawa, H., et al.[2016]

The Crit-Line® III and IV noninvasive blood volume monitors provide accurate estimates of packed cell volume (PCV) and changes in blood volume during ultrafiltration (UF) in dogs, although their accuracy varies with specific PCV ranges.

The study found that the monitors often reported lower hematocrit values compared to actual PCV and highlighted inaccuracies in targeted ultrafiltration rates, suggesting that veterinary practices should assess individual machines for these discrepancies to ensure effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Crit-Line® monitors in predicting hematocrit and change in blood volume of dogs during hemodialysis. Vickery, WE., Steinbach, SML., Moore, GE.[2023]

Ultrafiltration failure in peritoneal dialysis, defined as not achieving at least 400 ml of net ultrafiltration during a 4-hour dwell with 4.25% dextrose, is a major reason for patients needing to switch to hemodialysis.

Understanding the four main causes of ultrafiltration failure—high peritoneal transport state, low osmotic conductance to glucose, low effective peritoneal surface area, and high total peritoneal fluid loss—can help in diagnosing and managing this condition effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrafiltration failure in peritoneal dialysis: a pathophysiologic approach. Teitelbaum, I.[2022]

Ultrafiltration failure is a growing concern in patients on peritoneal dialysis, leading to increased cardiovascular risks and often resulting in the discontinuation of this treatment method.

This review highlights various strategies for preventing and treating ultrafiltration failure, emphasizing the importance of ongoing research to improve clinical outcomes for the increasing number of patients requiring renal replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective measures against ultrafiltration failure in peritoneal dialysis patients. Aguirre, AR., Abensur, H.[2022]

In a study of 53 patients with intradialytic hypotension (IDH) and water retention, the combination of ultrafiltration (UF) and haemodialysis (HD) significantly improved treatment outcomes, including greater water removal and weight loss compared to conventional HD.

The sequential UF and HD treatment also resulted in a lower incidence of IDH (0% in the treatment group vs. 75% in the control group), indicating a safer approach for managing patients who struggle with dehydration and fluid overload.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ultrafiltration combined with haemodialysis in patients with uraemia who cannot tolerate dialysis because of hypotension. Wang, Z., Li, H., Sun, L., et al.[2023]

Slow continuous ultrafiltration is a promising treatment for acute renal failure, offering advantages such as better blood pressure stability and no requirement for systemic anticoagulation.

In a small study involving two patients, this method was successfully used in hemodynamically unstable individuals, supporting its effectiveness in managing acute renal failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute renal failure treated by slow continuous ultrafiltration. Preliminary report. Synhaivsky, A., Kurtz, SB., Wochos, DN., et al.[2013]

In a study of 33,224 hemodialysis treatments involving 312 patients, intradialytic hypotension (IDH) was found to occur in 38.7% of sessions, highlighting its prevalence as a serious side effect of hemodialysis.

The study identified a critical threshold for ultrafiltration (UF) at a UF/weight ratio of 0.04, which can help predict and potentially prevent IDH, particularly in older patients and those with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between prescription of ultrafiltration and intradialytic hypotension in Chinese hemodialysis patients. Deng, F., Di, W., Ma, Y., et al.[2021]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04163614/blood-pressure-slopes-and-ultrafiltration-in-hemodialysis-patients

Blood Pressure Slopes and Ultrafiltration in Hemodialysis ... In this study, I aim to test a new strategy that prescribes fluid removal based on a patient's recent blood pressure patterns during dialysis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7215236/

Blood pressure and volume management in dialysis Blood pressure (BP) and volume control are critical components of dialysis care and have substantial impacts on patient symptoms, quality of life, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04163614

Blood Pressure Slopes and Ultrafiltration in Hemodialysis ... Other outcomes will include 1) change in post-HD ECV/body weight using multifrequency bioimpedance spectroscopy, 2) change in post-HD total peripheral ...

4. withpower.com withpower.com/trial/ibps-guided-ultrafiltration-for-kidney-failure-26772

IBPS-Guided Ultrafiltration for Kidney Failure Research shows that slow continuous ultrafiltration can be effective for patients with acute kidney failure, especially those who are unstable, as it helps ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/91/NCT03303391/Prot_SAP_000.pdf

Using Intradialytic Systolic Blood Pressure Slopes to Guide ... Based on our preliminary data, patients with lower than median IBPS had nadir blood pressure of. 108.4 (15.7) mmHg compared to 126.8 (13.1) ...