Health TrialsbyHealthPanel

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

ConditionsAKI - Acute Kidney InjuryPneumonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMohd Zulfakar Mazlan, MBBS

About this trial

The purpose of this study aimed to compare the efficacy of Oxiris (Baxter) and M100 filters on IL-6 as primary outcomes and other blood cell counts, blood biochemistry (serum urea, creatinine, potassium, sodium), inflammation indicators (CRP, PCT), as secondary outcomes and safety (28 days mortality as a primary outcome and coagulopathy, lifespan of filter, usage of vasopressor, clinical conditions (ventilator-free days, ICU and hospital- length of stay) as a secondary outcome), clinical conditions (ventilator-free days, ICU and hospital- length of stay), and mortality of patients with pneumonia-related AKI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All adult patients aged>18 years old

Diagnosis of septic shock

Diagnosis of KDIGO stage 3 acute renal failure

Disqualifiers

Moribund patient or patient that is expected to die within 72 hours

Pregnancy

patient with a bleeding tendency or known allergy to heparin

Trial design

Design model

Parallel

Treatments tested in this trial

  • oXiris filter

    Device

    Continuous Renal Replacement Therapy with the adsorption membrane filter Oxiris. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared.

  • M100 filter

    Device

    Continuous Renal Replacement Therapy with the adsorption membrane filter M100. The specific septic biomarkers such as interleukin 6(IL-6), procalcitonin (PCT), C-reactive protein (CRP) along with other routine blood investigation results taken at the beginning of therapy and 24 hours after the treatment will be compared.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: oXiris filterExperimental treatment 1 intervention
Group B: M100 filterActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

To measure the effectiveness of the oxiris filter in reducing septic biomarker levels IL-6

To measure the effectiveness of oxiris filter compared to the M100 filter in reducing the septic biomarker levels during CRRT. The baseline IL6 will be measured immediately before CRRT and post-CRRT

Time frame
24 hours
2

To compare the 28-days mortality of using oxiris filter during CRRT

To measure the 28-day mortality rate when using oxiris and M100 filter for CRRT. The 28-day mortality rate is calculated based on the number of deaths occurring within 28 days from a defined starting point, the start of CRRT.

Time frame
28 days

Secondary outcomes

1

To compare the risk infection of by using oxiris during CRRT

To measure the risk of infection rate when using oxiris filter for CRRT. An infection is defined as an infection of the CRRT catheter such as CRBSI.

Time frame
28 days
2

To compare the risk bleeding of using oxiris during CRRT

To measure the risk of bleeding rate when using oxiris filter for CRRT. Bleeding is defined as any bleeding noted such as gastrointestinal, urinary bleeding or respiratory tract bleeding.

Time frame
28 days
3

To compare the risk of ventilator-free days of using oxiris during CRRT

To measure the risk of ventilator-free day rate when using oxiris filter for CRRT. It is defined as the number of days within a specific period (usually 28 days) during which a patient is both alive and free from mechanical ventilation. For example, if a patient is on mechanical ventilation for 10 days and survives the entire 28-day period, they would have 18 ventilator-free days (28 - 10 = 18). If a patient dies at any point within the 28 days, their VFDs would be zero.

Time frame
28 days
4

To measure the effectiveness of the oxiris filter in reducing septic biomarker levels PCT

To measure the effectiveness of oxiris filter compared to the M100 filter in reducing the septic biomarker levels during CRRT. The baseline PCT will be measured immediately before CRRT and post-CRRT

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mohd Zulfakar Mazlan, MBBS

Lead sponsor

Universiti Sains Malaysia

Sponsor institution

Source ClinicalTrials.gov
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