Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06440759

Evaluation of Efficacy and Safety Using oXiris Versus M100 Filter in Pneumonia-induced Acute Kidney Injury Patients Requiring Continuous Renal Replacement Therapy

Led by Mohd Zulfakar Mazlan, MBBS · Updated on 2025-10-02

60

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the effectiveness and safety of two different hemofilters, Oxiris and M100, used during Continuous Renal Replacement Therapy (CRRT) in patients with pneumonia-related acute kidney injury (AKI) who also have septic shock. The study aims to compare how well these filters reduce levels of inflammatory markers such as interleukin 6 (IL-6), procalcitonin (PCT), and C-reactive protein (CRP). It also evaluates clinical outcomes including 28-day mortality, ventilator-free days, length of stay in intensive care and hospital, and other safety parameters. Participants are randomly assigned to receive CRRT with either the Oxiris filter or the M100 filter. The intervention lasts for at least 24 hours, during which blood parameters are closely monitored. If the filter clogs within 24 hours, the same type is replaced; if clogging occurs after 24 hours and CRRT is still needed, the M100 filter is used. The treatment continues until signs of kidney recovery appear, such as improved urine output and stable clinical conditions, or a decision is made to switch to intermittent dialysis. During the study, patients undergo blood tests at the start and 24 hours after treatment to measure septic biomarkers and routine biochemistry. Clinical conditions, including use of vasopressors, ventilator-free days, and length of hospital stay, are tracked. Mortality is recorded up to 28 days after ICU admission, with follow-up ensured through multiple contact methods and national registry checks. This comprehensive monitoring aims to assess the relative benefits and risks of each filter type in managing pneumonia-induced AKI with septic shock.

CONDITIONS

Brief Title

To Compare the Efficacy and Safety of Using oXiris and M100 During CRRT

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged over 18 years
  • Diagnosis of septic shock
  • Diagnosis of KDIGO stage 3 acute renal failure
Not Eligible

You will not qualify if you...

  • Moribund patients or those expected to die within 72 hours
  • Pregnancy
  • Patients with bleeding tendency or known allergy to heparin

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 24 hours or until CRRT is no longer needed

Participants receive Continuous Renal Replacement Therapy using either the oXiris or M100 filter. Blood tests for septic biomarkers and routine investigations are taken at the beginning of therapy and 24 hours after treatment.

Continuous therapy during treatment period with blood tests at start and 24 hours

Follow-up

Duration - 28 days

Participants are followed for 28 days after ICU admission to monitor outcomes including mortality and potential complications.

Follow-up contacts via phone or registry data collection

Trial Site Locations

Total: 1 location

1

Hospital Universiti Sains Malaysia (HUSM)

Kubang Kerian, Kelantan, Malaysia, 16150

Actively Recruiting

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Research Team

M

Marina Azidah Mat Zaid, MBBS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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