Online Hemodiafiltration vs Conventional Hemodialysis for Acute Kidney Injury

(HDFAKI Trial)

Recruiting at 1 trial location

Overseen By William Beaubien-Souligny, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Immunosuppressants

Disqualifiers: Pregnancy, Chronic dialysis, others

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

Compensation: Varies

Number of Visits: Unknown

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to see if Online Hemodiafiltration can better reduce inflammation and help kidney recovery in ICU patients with Acute Kidney Injury compared to regular dialysis. The study will check if this new method is feasible for larger trials.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on active immunosuppressive therapy, you are excluded from participating.

What data supports the idea that Online Hemodiafiltration vs Conventional Hemodialysis for Acute Kidney Injury is an effective treatment?

The available research shows that Online Hemodiafiltration (OL-HDF) may be more effective than Conventional Hemodialysis for some patients. Studies indicate that OL-HDF, especially with high volumes, is linked to lower death rates compared to conventional methods. For example, one study found that predilution OL-HDF was associated with better overall survival rates. Another study suggested that OL-HDF could improve patient survival by removing more toxins from the blood. These findings suggest that OL-HDF might be a better option for improving survival and quality of life in patients needing dialysis. ^{1 2 3 4 5}

What safety data exists for online hemodiafiltration and conventional hemodialysis?

Online hemodiafiltration (OL-HDF) has been associated with improved survival rates compared to conventional hemodialysis. Studies indicate that high volume post-dilution hemodiafiltration may lead to lower death rates. Predilution OL-HDF is linked to better overall survival, with high substitution volumes showing further benefits. However, large-scale data on clinical outcomes are still limited, and the superiority of OL-HDF over conventional hemodialysis has not been conclusively demonstrated in randomized controlled trials. ^{1 2 4 6 7}

Is Conventional Hemodialysis or Online Hemodiafiltration a promising treatment for Acute Kidney Injury?

Online Hemodiafiltration, especially in the post-dilution and pre-dilution forms, shows promise as it may improve survival rates and remove toxins more effectively than Conventional Hemodialysis. It is becoming more popular in countries like Japan, where it is associated with better patient outcomes. ^{1 2 3 4 8}

Research Team

Jean-Maxime Cote, MD, MSc

Principal Investigator

CHUM

Eligibility Criteria

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.

Inclusion Criteria

I am currently in the intensive care unit.

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

I am 18 years old or older.

Exclusion Criteria

You are already taking part in another study about dialysis treatments.

Subjects or relatives/next-of-kin unable to provide written informed consent

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

Treatment Details

Interventions

• Conventional Hemodialysis
• Online Post-dilution Hemodiafiltration
• Online Pre-dilution Hemodiafiltration

Trial Overview 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.

Participant Groups

Group I: Pre-dilution Hemodiafiltration Experimental Treatment 1 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 Hemodiafiltration Experimental Treatment 1 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 Hemodialysis Active Control 1 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).

Conventional Hemodialysis is already approved in United States, European Union for the following indications:

Approved in United States as Conventional Hemodialysis for:

• End-stage kidney disease
• Chronic kidney disease progressing to dialysis-dependent kidney disease

Approved in European Union as Conventional Hemodialysis for:

• End-stage kidney disease
• Chronic kidney disease progressing to dialysis-dependent kidney disease

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Findings from Research

A new simple mid-dilution OL-HDF technique was tested on 12 stable end-stage renal disease patients, showing high efficiency in clearing uremic toxins while minimizing protein loss.

This method combines the benefits of both pre- and post-dilution modes of hemodiafiltration, potentially reducing morbidity and mortality in hemodialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple efficient technique of 'mid-dilution' on-line hemodiafiltration. Susantitaphong, P., Tiranathanagul, K., Hanvivatvong, O., et al.[2016]

A study involving 10,000 patients (5,000 pairs) found that predilution on-line hemodiafiltration is associated with improved overall survival compared to conventional hemodialysis, with a hazard ratio of 0.83 for all-cause mortality.

Patients receiving higher substitution volumes (≥40.0 L per session) during predilution on-line hemodiafiltration showed even better survival rates, suggesting that optimizing substitution volume may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predilution online hemodiafiltration is associated with improved survival compared with hemodialysis. Kikuchi, K., Hamano, T., Wada, A., et al.[2020]

Predilution on-line hemodiafiltration (OL-HDF) is preferred in Japan for its ability to increase substitution volume at lower blood flow rates and effectively remove larger low-molecular-weight proteins, potentially improving patient outcomes.

Recent studies indicate that predilution OL-HDF may offer significant survival benefits, particularly in reducing all-cause and cardiovascular mortality, while also maintaining hemodynamic stability compared to postdilution methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for the Clinical Advantages of Predilution On-Line Hemodiafiltration. Masakane, I., Kikuchi, K., Kawanishi, H.[2018]

High volume post-dilution hemodiafiltration may lead to lower death rates compared to conventional hemodialysis, as suggested by post-hoc analyses of previous trials.

The study aims to determine whether the benefits of high volume hemodiafiltration are due to the convection volume achieved or the duration of dialysis required to reach these high volumes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High volume online post-dilution hemodiafiltration: how relevant is it in chronic kidney disease? Castro, MCM.[2022]

The HOLLANT study is a multicenter trial involving 40 dialysis patients, designed to investigate whether high-volume online hemodiafiltration (HV-HDF) reduces the incidence of intradialytic hypotension (IDH), which may contribute to better overall and cardiovascular survival compared to standard hemodialysis.

The study will assess various outcomes, including blood pressure changes, heart function, organ damage, and patient-reported symptoms, to understand the mechanisms behind the potential benefits of HV-HDF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of various dialysis modalities on intradialytic hemodynamics, tissue injury and patient discomfort in chronic dialysis patients: design of a randomized cross-over study (HOLLANT). Rootjes, PA., Nubé, MJ., de Roij van Zuijdewijn, CLM., et al.[2022]

Online hemodiafiltration (OL-HDF) is associated with a reduced risk of mortality compared to standard hemodialysis, making it a recommended first-line treatment for hemodialysis patients.

To maximize the benefits of OL-HDF, it is advised to achieve a convective volume greater than 23 liters per session, using the highest possible blood flow and infusion rates, although there is no evidence to support normalizing the convective dose to body size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There an 'Optimal Dose' of Hemodiafiltration? Maduell, F.[2015]

A pilot study involving 51 patients assessed the feasibility and safety of incremental-start hemodialysis (HD), showing high adherence rates (96%) to the treatment schedule and successful enrollment in a randomized study.

Patients in the incremental HD group experienced less decline in urine volume and solute clearance compared to those receiving conventional thrice-weekly HD, suggesting potential benefits of this approach, although further research with larger trials is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twice-Weekly Hemodialysis With Adjuvant Pharmacotherapy and Transition to Thrice-Weekly Hemodialysis: A Pilot Study. Murea, M., Patel, A., Highland, BR., et al.[2023]

Postdilution online hemodiafiltration (HDF) has been clinically established as beneficial, leading to a significant increase in its use in Japan, where it accounted for 10% of the dialysis population by the end of 2013.

In Japan, predilution online HDF is predominantly used (90.8% of cases) due to lower blood flow rates, which allows for reduced albumin loss and less membrane fouling, although there is currently insufficient evidence to support its clinical advantages over conventional hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Expectation of Online Hemodiafiltration: A Japanese Perspective. Akizawa, T., Koiwa, F.[2015]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A simple efficient technique of 'mid-dilution' on-line hemodiafiltration. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Predilution online hemodiafiltration is associated with improved survival compared with hemodialysis. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Evidence for the Clinical Advantages of Predilution On-Line Hemodiafiltration. [2018]

4. Brazil pubmed.ncbi.nlm.nih.gov

High volume online post-dilution hemodiafiltration: how relevant is it in chronic kidney disease? [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effect of various dialysis modalities on intradialytic hemodynamics, tissue injury and patient discomfort in chronic dialysis patients: design of a randomized cross-over study (HOLLANT). [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Is There an 'Optimal Dose' of Hemodiafiltration? [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Twice-Weekly Hemodialysis With Adjuvant Pharmacotherapy and Transition to Thrice-Weekly Hemodialysis: A Pilot Study. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Expectation of Online Hemodiafiltration: A Japanese Perspective. [2015]