What is the mechanism of action of this treatment?

Dialysis is a key treatment for Acute Kidney Injury (AKI), particularly when the kidneys fail to filter waste and excess fluids. The standardized dialysis strategy, or uniform dialysis protocol, ensures consistent and optimized care by following a set regimen. This approach helps in the timely removal of toxins and maintaining fluid balance, which is essential for preventing complications and promoting kidney recovery. Standardizing treatment reduces variability in care, potentially leading to better patient outcomes and more efficient resource use.

What side effects are associated with this type of intervention?

The most common treatment for Acute Kidney Injury (AKI) is dialysis, which can have several side effects. These include hypotension (low blood pressure), muscle cramps, itching, sleep problems, anemia, bone diseases, and fluid overload. Infections at the access site and cardiovascular complications are also potential risks. Additionally, patients may experience fatigue and electrolyte imbalances. These side effects highlight the importance of careful monitoring and individualized treatment plans.

What prior FDA approvals exist?

There are no specific FDA-approved drugs solely for the treatment of Acute Kidney Injury (AKI). The management of AKI often involves supportive care, including dialysis. The Standardized Dialysis Strategy trial aims to evaluate a uniform dialysis protocol compared to usual care, which typically involves dialysis prescriptions tailored by individual nephrologists. This approach is part of ongoing efforts to optimize dialysis strategies for better outcomes in AKI patients.

What other types of research exist?

Promising novel alternatives to the Standardized Dialysis Strategy for Acute Kidney Injury patients include personalized dialysis protocols tailored to individual patient needs, the use of regional citrate anticoagulation to reduce complications, and the early initiation of renal replacement therapy. Continuous treatments and advancements in dialysis technology also offer potential improvements in patient outcomes.

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Standardized Dialysis for Acute Kidney Injury (Recover-AKI Trial)

N/A

Waitlist Available

Led By Samuel A Silver

Research Sponsored by Samuel Silver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Plans for continued intermittent hemodialysis or sustained low efficiency dialysis treatments

Received ≥2 sessions of any dialysis modality for presumed AKI

Must not have

Strong clinical suspicion of urinary tract obstruction, rapidly progressive glomerulonephritis (RPGN), vasculitis, thrombotic microangiopathy (TMA), myeloma related cast nephropathy, or acute interstitial nephritis (AIN) as the underlying cause of AKI

Receipt of dialysis for ≥90 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

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 treatment specifics. The study focuses on patients with Acute Kidney Injury who are already receiving dialysis. The goal is to see if a standardized approach can improve care or make it easier to manage.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical risks of dialysis can include low blood pressure, muscle cramps, itching, sleep problems and infections. The structured approach may alter these risks but details would be provided during the consent process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am planning to continue with my dialysis treatments.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been on dialysis for at least 90 days.

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I had a kidney transplant within the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fidelity

Recruitment

Secondary study objectives

Dialysis-Free Days

Hypotensive Event on Dialysis

Other study objectives

Arrhythmia on Dialysis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standardized Dialysis and Structured Discontinuation (S2D2)Experimental Treatment1 Intervention

Prescription to minimize dialysis-induced ischemia and standardize dialysis discontinuation

Group II: Usual CareActive Control1 Intervention

Dialysis prescription ordered by their primary nephrologist/intensivist.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dialysis is a key treatment for Acute Kidney Injury (AKI), particularly when the kidneys fail to filter waste and excess fluids. The standardized dialysis strategy, or uniform dialysis protocol, ensures consistent and optimized care by following a set regimen. This approach helps in the timely removal of toxins and maintaining fluid balance, which is essential for preventing complications and promoting kidney recovery. Standardizing treatment reduces variability in care, potentially leading to better patient outcomes and more efficient resource use.