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)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marina Azidah Mat Zaid, MBBS
- Phone Number: 0199870715
- Email: marinazaid@yahoo.com
Study Locations
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Kelantan
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Kubang Kerian, Kelantan, Malaysia, 16150
- Recruiting
- Hospital Universiti Sains Malaysia (HUSM)
-
Contact:
- Mohd Zulfakar Mazlan, MBBS
- Phone Number: 6104 +6097673000
- Email: zulfakar@usm.my
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
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. |
|
Active Comparator: 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To measure the effectiveness of the oxiris filter in reducing septic biomarker levels IL-6
Time Frame: 24 hours
|
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
Time Frame: 28 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare the risk infection of by using oxiris during CRRT
Time Frame: 28 days
|
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.
|
28 days
|
|
To compare the risk bleeding of using oxiris during CRRT
Time Frame: 28 days
|
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.
|
28 days
|
|
To compare the risk of ventilator-free days of using oxiris during CRRT
Time Frame: 28 days
|
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.
|
28 days
|
|
To measure the effectiveness of the oxiris filter in reducing septic biomarker levels PCT
Time Frame: 24 hours
|
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
|
24 hours
|
|
To measure the effectiveness of the oxiris filter in reducing septic biomarker levels CRP
Time Frame: 24 hours
|
To measure the effectiveness of oxiris filter compared to the M100 filter in reducing the septic biomarker levels during CRRT.
The baseline CRP will be measured immediately before CRRT and Post CRRT
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USM/JEPeM/KK/23090718
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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