Clinical trial NCT06440759: To Compare the Efficacy and Safety of Using oXiris and M100 During CRRT
Official title: Evaluation of Efficacy and Safety Using oXiris Versus M100 Filter in Pneumonia-induced Acute Kidney Injury (AKI) Patients Requiring Continuous Renal Replacement Therapy (CRRT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: AKI - Acute Kidney Injury
Pneumonia
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To measure the effectiveness of the oxiris filter in reducing septic biomarker levels IL-6
timeFrame: 24 hours
measure: To compare the 28-days mortality of using oxiris filter during CRRT
timeFrame: 28 days
Secondary outcomes:
measure: To compare the risk infection of by using oxiris during CRRT
timeFrame: 28 days
measure: To compare the risk bleeding of using oxiris during CRRT
timeFrame: 28 days
measure: To compare the risk of ventilator-free days of using oxiris during CRRT
timeFrame: 28 days
measure: To measure the effectiveness of the oxiris filter in reducing septic biomarker levels PCT
timeFrame: 24 hours
measure: To measure the effectiveness of the oxiris filter in reducing septic biomarker levels CRP
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Hospital Universiti Sains Malaysia (HUSM)
state: Kelantan
Study officials:
References: