To Compare the Efficacy and Safety of Using oXiris and M100 During CRRT
Evaluation of Efficacy and Safety Using oXiris Versus M100 Filter in Pneumonia-induced Acute Kidney Injury (AKI) Patients Requiring Continuous Renal Replacement Therapy (CRRT)
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2024
CompletedStudy Start
First participant enrolled
May 30, 2024
CompletedFirst Posted
Study publicly available on registry
June 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedOctober 2, 2025
September 1, 2025
1.5 years
April 30, 2024
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
24 hours
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.
28 days
Secondary Outcomes (5)
To compare the risk infection of by using oxiris during CRRT
28 days
To compare the risk bleeding of using oxiris during CRRT
28 days
To compare the risk of ventilator-free days of using oxiris during CRRT
28 days
To measure the effectiveness of the oxiris filter in reducing septic biomarker levels PCT
24 hours
To measure the effectiveness of the oxiris filter in reducing septic biomarker levels CRP
24 hours
Study Arms (2)
oXiris filter
EXPERIMENTALContinuous 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. The 28-day mortality will be recorded following treatment.
M100 filter
ACTIVE COMPARATORContinuous 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. The 28-day mortality will be recorded following treatment.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- All adult patients aged\>18 years old
- Diagnosis of septic shock
- Diagnosis of KDIGO stage 3 acute renal failure
You may not qualify if:
- Moribund patient or patient that is expected to die within 72 hours
- Pregnancy
- patient with a bleeding tendency or known allergy to heparin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universiti Sains Malaysia (HUSM)
Kubang Kerian, Kelantan, 16150, Malaysia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- single-blinding (patient)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 30, 2024
First Posted
June 4, 2024
Study Start
May 30, 2024
Primary Completion
December 1, 2025
Study Completion
May 1, 2026
Last Updated
October 2, 2025
Record last verified: 2025-09