Standardized Dialysis for Acute Kidney Injury

(Recover-AKI Trial)

Overseen By Samuel A Silver

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Samuel Silver

Disqualifiers: Dialysis ≥90 days, eGFR <15, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines different dialysis methods for individuals with acute kidney injury (AKI). It compares a new, standardized method called Standardized Dialysis and Structured Discontinuation (S2D2) to the usual care determined by a patient's doctor. The researchers aim to determine if the new method is more effective and easier to manage. Individuals who have undergone at least two dialysis sessions for AKI and plan to continue regular dialysis may be suitable candidates. As an unphased trial, this study provides patients the chance to contribute to innovative research that could enhance dialysis care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this dialysis strategy is safe for patients with acute kidney injury?

Research has shown that regular dialysis can help manage sudden kidney problems, known as acute kidney injury (AKI). However, limited information exists about the safety of a specific method called "Standardized Dialysis and Structured Discontinuation (S2D2)." The safety details for this method remain unclear.

Dialysis is a common and generally well-tolerated treatment for kidney issues. This study focuses on using a consistent method to potentially improve patient outcomes. The goal is to reduce problems caused by dialysis, such as reduced blood flow, and to standardize how dialysis is stopped. Although specific safety data for S2D2 is lacking, a standardized approach might lower risks by providing a more consistent treatment plan.

In summary, while direct evidence about safety concerns from these sources is not available, dialysis is a widely accepted procedure. This trial aims to improve its implementation, which could enhance safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Standardized Dialysis and Structured Discontinuation (S2D2) protocol because it offers a new way to manage acute kidney injury (AKI) by minimizing dialysis-induced ischemia and providing a systematic approach to stopping dialysis. Unlike the usual care, where dialysis is prescribed based on the judgment of individual nephrologists or intensivists, S2D2 aims to standardize the process, potentially reducing complications and improving patient outcomes. By focusing on a consistent and evidence-based method, S2D2 could lead to more predictable and safer results for patients with AKI.

What evidence suggests that this trial's treatments could be effective for acute kidney injury?

Research has shown that about one-third of patients with acute kidney injury who require dialysis can recover enough to stop dialysis after leaving the hospital. In this trial, participants will join one of two treatment arms. One arm will receive Standardized Dialysis and Structured Discontinuation (S2D2), a method that might improve recovery compared to usual care by reducing issues from reduced blood flow during dialysis and establishing clear guidelines for stopping dialysis. The other arm will receive Usual Care, with dialysis prescribed by their primary nephrologist or intensivist. Unlike traditional methods that rely on individual doctors' decisions, the standardized method offers a consistent approach to managing treatment, which might aid kidney recovery. However, further research is needed to confirm its effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Samuel A Silver

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

This trial is for patients who have had acute kidney injury and received at least two dialysis sessions, with plans to continue. It's not for those on dialysis for over 90 days, with certain pre-existing conditions like severe chronic kidney disease or specific acute renal diseases, recent kidney transplant recipients, or pregnant individuals.

Inclusion Criteria

I am planning to continue with my dialysis treatments.

I have undergone at least 2 dialysis treatments for acute kidney injury.

Exclusion Criteria

I am suspected to have a serious kidney condition causing my acute kidney injury.

Pregnant

I have not had dialysis in the last 2 months before this hospital visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a standardized dialysis strategy or usual care as prescribed by their primary nephrologist

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including dialysis-free days and hypotensive events

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Standardized Dialysis and Structured Discontinuation (S2D2)
• Usual Care

Trial Overview The study compares a standardized dialysis strategy (S2D2) against the usual care where each patient's primary nephrologist decides the treatment. The aim is to see if it's feasible to do a larger trial on this approach in patients recovering from acute kidney injury.

How Is the Trial Designed?

Group I: Standardized Dialysis and Structured Discontinuation (S2D2) Experimental Treatment 1 Intervention

Prescription to minimize dialysis-induced ischemia and standardize dialysis discontinuation

Group II: Usual Care Active Control 1 Intervention

Dialysis prescription ordered by their primary nephrologist/intensivist.

Who Is Running the Clinical Trial?

Samuel Silver

Lead Sponsor

Trials

2

Recruited

510+

Samuel Silver

Lead Sponsor

Trials

2

Recruited

510+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04948476

NCT04948476 | Promoting Kidney Recovery After Acute ... The overall goal of this study is to evaluate the feasibility of conducting a randomized controlled trial comparing a standardized dialysis strategy versus ...

2. withpower.com withpower.com/trial/phase-acute-kidney-injury-2022-9f7ad

Standardized Dialysis for Acute Kidney Injury (Recover-AKI ... This trial aims to test if using a consistent method for performing dialysis is feasible compared to letting each patient's kidney doctor decide the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949813925000084

Clinical Trials Targeting Recovery and Postdischarge Care ... Trials of pharmaceuticals including diuretics have not improved dialysis for acute kidney injury recovery. •. Based on data from the Acute Renal Failure Trial ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11230726/

Acute Kidney Injury Receiving Dialysis and Dialysis Care after ... Approximately one third of patients with AKI-D who receive outpatient dialysis after hospital discharge survive and regain sufficient kidney function to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9755056/

Outcomes associated with acute kidney disease Our results showed that the patients with AKD had a higher risk of mortality, end-stage kidney disease (ESKD), incident CKD, and progressive CKD ...

6. cell.com cell.com/iscience/fulltext/S2589-0042(24)01622-5

Risk prediction models for successful discontinuation in ... Development and validation of outcome prediction models for acute kidney injury patients undergoing continuous renal replacement therapy.