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

NCT ID: NCT06440759

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2026-05-01

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.

Detailed Description

The type of hemofilter will be decided using a simple randomization. For the intervention group, only the oxiris filter will be used during the treatment period, while for the control group, the M100 filter will be used throughout the treatment. If the filter becomes clogged within 24 hours, the investigator will replace it with the same filter as the previous one. However, if the filter becomes clogged after 24 hours and the patient still requires CRRT, the investigator will replace it with M100. This change in filter type will not affect the study results, as only the blood parameters during the first 24 hours of treatment will be evaluated for objective one. The oxiris filter will be used for the first 24 hours, or whichever is longer, and will be replaced with an M100 filter if indicated for both groups. Therefore, it will not affect the outcome of objective two compared to the standard arm group

Termination of CRRT will be done according to recent studies once the patient fulfills either one or more of these criteria: urine output and serum creatinine are indicative of kidney recovery, vasopressor cessation, increased urine output ≥500ml/24H without diuretics, correction of fluid overload, hemodynamic stability and the possible need to shift to intermittent dialysis.

The patient will be followed up until 28 days following ICU admission. To avoid any missing data, at least 3 contact numbers will be made available. If unable to get in contact with the patient, the application status of alive or dead will be applied to a national registry.

Conditions

AKI - Acute Kidney Injury; Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

oXiris filter

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.

The 28-day mortality will be recorded following treatment.

Group Type: EXPERIMENTAL

oXiris filter

Intervention Type: 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

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.

The 28-day mortality will be recorded following treatment.

Group Type: ACTIVE_COMPARATOR

M100 filter

Intervention Type: 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.

Interventions

oXiris filter

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.

Intervention Type: DEVICE

M100 filter

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All adult patients aged>18 years old
• Diagnosis of septic shock
• Diagnosis of KDIGO stage 3 acute renal failure

Exclusion Criteria

• Moribund patient or patient that is expected to die within 72 hours
• Pregnancy
• patient with a bleeding tendency or known allergy to heparin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mohd Zulfakar Mazlan, MBBS

OTHER

Sponsor Role: lead

Responsible Party

Mohd Zulfakar Mazlan, MBBS

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Universiti Sains Malaysia (HUSM)

Kubang Kerian, Kelantan, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Marina Azidah Mat Zaid, MBBS

Role: CONTACT

marinazaid@yahoo.com

0199870715

Facility Contacts

Mohd Zulfakar Mazlan, MBBS

Role: primary

zulfakar@usm.my

+6097673000 ext. 6104

Other Identifiers

USM/JEPeM/KK/23090718

Identifier Type: -

Identifier Source: org_study_id