What is the mechanism of action of this treatment?

The most common treatments for Acute Kidney Injury (AKI) include conventional intermittent hemodialysis, continuous renal replacement therapy (CRRT), and online hemodiafiltration. These treatments work by removing waste products and excess fluid from the blood, which the damaged kidneys can no longer efficiently filter. Online hemodiafiltration, in particular, combines diffusion and convection mechanisms to enhance the removal of larger molecules and reduce inflammation, potentially leading to better renal recovery. This is crucial for AKI patients as it helps to stabilize their condition, prevent complications, and support the healing process of the kidneys.

What side effects are associated with this type of intervention?

Common treatments for Acute Kidney Injury (AKI), such as conventional hemodialysis and hemodiafiltration, can have several side effects. These include hypotension (low blood pressure), muscle cramps, and infections related to catheter use. Other complications may involve bleeding, cardiac arrhythmias, and metabolic imbalances like citrate-induced metabolic alkalosis. Hemodiafiltration, which combines diffusion and convection, is being studied for its potential to reduce inflammation and improve renal recovery, but it may also share similar side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Kidney Injury (AKI), primarily focusing on supportive care and addressing underlying causes. While specific FDA approvals for therapies combining diffusion and convection, like Online Hemodiafiltration, are limited, conventional hemodialysis remains a standard treatment. Additionally, pharmaceutical agents such as diuretics and vasopressors are used to manage fluid balance and blood pressure in AKI patients. Recent clinical trials have explored novel agents like QPI-1002 and human recombinant alkaline phosphatase (recAP) for their potential to reduce inflammation and improve renal recovery, though these are still under investigation and not yet FDA-approved.

What other types of research exist?

Promising novel alternatives to Online Hemodiafiltration for Acute Kidney Injury patients include: 1) Hemoperfusion, which uses adsorbent cartridges to remove inflammatory mediators and toxins from the blood, potentially reducing inflammation and improving outcomes. 2) High-Volume Hemofiltration (HVHF), which involves the use of large volumes of replacement fluid to enhance the removal of inflammatory mediators and improve hemodynamic stability. 3) Bioartificial Kidney Devices, which combine living renal cells with synthetic materials to replicate kidney functions and support renal recovery. These alternatives are currently under research and may offer new avenues for treatment in the near future.

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Online Hemodiafiltration vs Conventional Hemodialysis for Acute Kidney Injury (HDFAKI Trial)

N/A

Recruiting

Led By Jean-François Cailhier, MD, PhD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

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

Must have

Hospitalised in the ICU

Requiring RRT for AKI, as judged by the attending clinician (initiation) or conversion from CRRT to intermittent dialysis

Must not have

Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study

Subjects on active immunosuppressive therapy (>10mg of prednisone, biologic therapies, calcineurin inhibitors, mTOR inhibitors or antimetabolites)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

HDFAKI Trial Summary

This trial is testing whether a new kind of dialysis, called Online Hemodiafiltration, reduces inflammation and improves kidney recovery in patients with Acute Kidney Injury.

Who is the study for?

This trial is for adults over 18 in the ICU with severe acute kidney injury needing renal replacement therapy, not on chronic dialysis or immunosuppressive drugs, and not pregnant. They must be able to consent and not involved in other dialysis studies.Check my eligibility

What is being tested?

The study tests if Online Hemodiafiltration (pre-dilution or post-dilution) can reduce inflammation and improve kidney recovery compared to Conventional Hemodialysis in ICU patients with acute kidney injury.See study design

What are the potential side effects?

Potential side effects may include reactions related to fluid removal like low blood pressure, muscle cramps, nausea; anticoagulation-related issues such as bleeding; and possible infection risks at the vascular access site.

HDFAKI Trial Eligibility Criteria

Inclusion Criteria

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

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I am currently in the intensive care unit.

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I need dialysis for acute kidney injury as decided by my doctor.

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I have severe kidney injury.

Exclusion Criteria

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

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I am not pregnant, breastfeeding, or planning to become pregnant during the study.

Select...

I am currently on strong immunosuppressive medication.

Select...

I cannot take blood thinners during dialysis.

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My kidney function is severely reduced or I am on dialysis.

HDFAKI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to follow-up (feasibility)

Participant accrual (feasibility)

Protocol adherence (feasibility)

Secondary outcome measures

Dialysis dependence

End-of-study eGFR

Length of hospitalisation stay

+4 more

Other outcome measures

(Exploratory) Inflammatory serum biomarkers modulation

(Exploratory) Phenotype of circulation monocytes

(Exploratory) Phenotype of circulation neutrophils

HDFAKI Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Pre-dilution HemodiafiltrationExperimental Treatment1 Intervention

Participants will receive intermittent pre-dilution HDF for a minimum of 4hours per session, 3 to 4 times/week, using the 5008 High-Volume HDF Machine from Fresenius Medical Care with High Flux FX1000 Dialyzer (Mode pre-dilution HDF).

Group II: Post-dilution HemodiafiltrationExperimental Treatment1 Intervention

Participants will receive intermittent post-dilution HDF for a minimum of 4hours per session, 3 to 4 times/week, using the 5008 High-Volume HDF Machine from Fresenius Medical Care with High Flux FX1000 Dialyzer (Mode post-dilution HDF).

Group III: Conventional HemodialysisActive Control1 Intervention

Participants will receive intermittent HD for a minimum of 4hours per session, 3 to 4 times/week, using the 5008 High-Volume HDF Machine from Fresenius Medical Care with High Flux FX1000 Dialyzer (Mode HD).

0 / 7Eligibility 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

The most common treatments for Acute Kidney Injury (AKI) include conventional intermittent hemodialysis, continuous renal replacement therapy (CRRT), and online hemodiafiltration. These treatments work by removing waste products and excess fluid from the blood, which the damaged kidneys can no longer efficiently filter. Online hemodiafiltration, in particular, combines diffusion and convection mechanisms to enhance the removal of larger molecules and reduce inflammation, potentially leading to better renal recovery. This is crucial for AKI patients as it helps to stabilize their condition, prevent complications, and support the healing process of the kidneys.