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RecruitingNCT06227104Updated Jan 26, 2024

Efficacy of Convection-based HDF Compare With Diffusion-based HD in Sepsis-associated AKI

An interventional study of Convection-based Hemodiafiltration in Primary Outcome : Compare Percent CRP Reduction and Secondary Outcome : 30-day Mortality, Renal Recovery, Length of Hospital Stay, sponsored by Ramathibodi Hospital. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-26.

Sponsored by Ramathibodi Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2024, 2 years 8 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled Jun 2023, registered Jan 2024).
  • Started Jun 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Acute kidney injury (AKI) is a common complication among patient admitted in the hospital worldwide, with estimates of prevalence ranging from less than 1% to 66%.1, 2 In critically ill patients approximately 49% were acute kidney injury network (AKIN) stage 3 which required intensive care unit (ICU) admission, kidney replacement therapy (KRT), and is associated with higher mortality rate.3 Sepsis-associated acute kidney injury (S-AKI) is a frequent complication in critically ill patient and is associated with high morbidity and mortality. S-AKI is defined as AKI in presence of sepsis without other significant contributing factors or simultaneous presence of both Sepsis-3 definition and Kidney Disease Improving Global Outcomes (KDIGO) criteria for AKI. 4, 5 Multicentre studies show that 30-60% of critically ill patient having AKI, and approximately 10-15% require KRT.6 Both Online-hemodiafiltration (OL-HDF) which is convection-based hemodiafiltration and conventional intermittent hemodialysis (IHD) which is diffusion-based hemodialysis are modalities of KRT that can be used to treat AKI in sepsis.7 Conventional intermittent hemodialysis (IHD) involves the removal of waste products and excess fluids from the blood by using a semipermeable membrane that acts as an artificial kidney. However, IHD has limitations in removing certain larger solutes, such as cytokines, which are involved in the inflammatory response associated with sepsis. In contrast, OL-HDF is a more advanced form of hemodialysis (HD) that combines convective clearance with diffusive clearance, resulting in more efficient removal of larger solutes.8 Several studies have suggested that OL-HDF may have advantages over conventional HD in the management of sepsis-associated AKI.9 Some studies found that OL-HDF was associated with improved patient survival and lower incidence of dialysis dependence compared to conventional IHD. Additionally, some studies have suggested that OL-HDF may have anti-inflammatory effects, which could be beneficial in sepsis.9-11 Some observational studies have shown that OL-HDF provide benefit over IHD including, a reduction in the length of ICU stay and a decrease in inflammatory surrogate markers. However, the effect of OL-HDF in improving survival has not yet been established. 1, 7, 9 Some studies have shown that sustained low-efficiency dialysis (SLED) may has advantage in hospital survival in over the continuous veno-venous hemofiltration (CVVH) modality.12 While there are several extracorporeal treatment modalities for AKI in critically ill patients but no randomized study has yet demonstrated a survival benefit over another.

A prospective and comparative study between IHD and OL-HDF groups showed no significant difference in mortality between the groups. However, a significant benefit in terms of a reduced length of ICU stays and vasopressor free day was found in the OL-HDF group.13 The past studies show that CRP and IL-6 levels increase in patients treated with IHD and remain stable in patients treated with OL-HDF, with a statistically significant difference. 14 In AKI patient, our aim is to remove small molecules such as uremic toxin or metabolic abnormalities. In chronic kidney disease, the benefit of high flux dialyser or OL-HDF to remove middle to large molecule such as ß2-microglobulin and others chronic inflammation molecules and cytokines through a combination of diffusion-based and convection-based techniques are well-known. These cytokines including C-reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), procalcitonin (PCT), which are commonly elevated in AKI patient, have been shown to be significantly reduced by using hemodiafiltration techniques. 9, 15 However, the benefits of removing middle molecule and inflammatory makers in the acute setting such as AKI in critically ill patient remain controversial.11, 16, 17 Therefore, this study aims to verify the benefit of convection-based treatment in reducing inflammatory molecule such as CRP over diffusion-based treatment in both critically-ill and standard AKI patients.

However, it is important to note that OL-HDF requires specialized equipment and may be more complex to administer compared to conventional IHD. Additionally, it is generally more expensive. Therefore, the choice of KRT modality in sepsis-associated AKI should be based on careful consideration of the individual patient's clinical status and available resources.7 It is important to note that every patient's condition is unique and requires individualized treatment, so the specific choice of KRT modality should be made in consultation with a healthcare professional.

Read the detailed description

Study design: Stratified randomized controlled trial, parallel group Population: Sepsis-associated AKI requiring KRT patient Hospital: Ramathibodi hospital and Chakri Naruebodindra Medical Institute (CNMI) Randomization: Stratified Randomization based on hemodynamics of the patient (envelope technique)

  • In hemodynamic unstable group (allocation 1:1) Sustained low-efficiency diafiltration (SLED-f) vs. Sustained low-efficiency dialysis (SLED) SLED-f is representative of convection-based KRT in critically ill patient. Dialysis prescription: Nikkiso DBB-05 (Tokyo Japan) Hemodiafiltration machine, High-flux polysulfone (Elisio 190HR) dialyzer (Nipro, Japan), minimum blood flow rate (BFR) 200-250 ml/min, minimum dialysate flow rate (DFR) 300 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38 mmol/L, dialysate temperature 35.5-36.5oC, dialysis duration 4-8 hrs, heparin 500 unit/hr if no contraindication, replacement fluid (online pre-dilution technique) with minimum flow rate 100 ml/min SLED is representative of diffusion-based KRT in critically ill patient which is currently a standard of dialysis care in hemodynamic unstable AKI patient.

Dialysis prescription: Fresenius 4008 (Bad homburg, Germany) hemodialysis machine, low-flux polysulfone (Elisio 170L) dialyzer (Nipro, Japan), minimum BFR 150-250 ml/min, minimum DFR 300 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38 mmol/L, dialysate temperature 35.5-36.5 oC, dialysis duration 4-8 hrs, heparin 500 unit/hr if no contraindication

  • In hemodynamic stable group (allocation 1:1) Online hemodiafiltration (OL HDF) vs. Intermittent hemodialysis (IHD) OL HDF is representative of convection-based KRT in hemodynamic stable AKI patient Dialysis prescription: Nikkiso DBB-05 (Tokyo, Japan) or Fresenius 5008 (Bad homburg, Germany) online-hemodialysis machine, high-flux polysulfone (Elisio 190HR) dialyzer (Nipro, Japan), minimum BFR 200-300 ml/min, DFR 500 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38, dialysate temperature 35.5-36.5oC, dialysis duration 4 hrs, heparin 500 unit/hr if no contraindication, replacement fluid (online pre-dilution technique) with minimum flow rate 100 ml/min IHD is representative of diffusion-based dialysis treatment which is currently a standard of dialysis care in hemodynamic stable AKI patient.

Dialysis prescription: Fresenius 4008 (Bad homburg, Germany) hemodialysis machine, low-flux polysulfone (Elisiio 170L) dialyzer (Nipro, Japan), minimum BFR 200-300 ml/min, DFR 500 ml/min, dialysate Ca 2.5-3.5, Na 135-140, HCO3 35-38, dialysate temperature 35.5-36.5 oC, dialysis duration 4 hrs, heparin 500 unit/hr if no contraindication

02

Conditions studied

  • Primary Outcome : Compare Percent CRP Reduction
  • Secondary Outcome : 30-day Mortality, Renal Recovery, Length of Hospital Stay
03

In context

Lead sponsor

Ramathibodi Hospital is the lead sponsor of 63 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Sepsis-associated AKI requiring KRT
  • Age >18 years old

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Patients with end stage kidney disease who are currently receiving kidney replacement therapy (chronic hemodialysis, peritoneal dialysis, kidney transplantation)
  • Patient who has refused to consent
  • Patient who dead or aim to dead within 24 hours after randomization
  • Patient who is receiving very high dose of vasopressor (norepinephrine > 1 mcg/kg/min)
  • Patient who is receiving CRRT at first randomization
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Online hemodiafiltration (OL HDF)

    Prescription: Nikkiso DBB-05 or Fresenius 5008 machine, high-flux polysulfone dialyzer, BFR 200-300, DFR 500, duration 4 hrs

    Device: Convection-based Hemodiafiltration

  • No intervention
    Intermittent hemodialysis (IHD)

    Fresenius 4008 hemodialysis machine, low-flux polysulfone (Elisiio 170L) dialyzer, minimum BFR 200-300, DFR 500, duration 4 hrs

Interventions

  • DeviceConvection-based Hemodiafiltration

    Convection-based Hemodiafiltration with pre substitution fluid

06

What researchers measure

Primary outcomes

  1. percent CRP reduction

    compare percent change of CRP before HD vs after HD

    Time frame: before and after 4 hours of HD and at 48 hours or before second HD

Secondary outcomes

  1. 30-day mortality rate, renal recovery rate, length of hospital stay

    compare difference between group

    Time frame: at 30 days after allocation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2023 (actual). Primary completion is estimated for Mar 2024, 9 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2024
First posted
Jan 26, 2024
StartActual
Jun 1, 2023
Primary completionEst.
Mar 1, 2024
CompletionEst.
Apr 1, 2024
Last update
Jan 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06227104
Lead sponsor
Ramathibodi Hospital
Collaborators
Arkom Nongnuch, Supawadee Suppadungsuk, Adisorn Pathumarak
Responsible party
Chamanant Satjanon (Nephrology Fellow, Ramathibodi Hospital) — Principal investigator
First posted
Jan 26, 2024
Start date
Jun 1, 2023
Primary completion
Mar 1, 2024 (estimated)
Completion
Apr 1, 2024 (estimated)
Last update
Jan 26, 2024

Study contacts

Chamanant Satjanon, MD
Contact
may.ninthnov@gmail.com
+66896968108
Adisorn Pathumarak, MD
Contact
adisorn.pat@mahidol.ac.th
+66896677980
Chamanant Satjanon, MD
principal investigator · Ramathibodi Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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