Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440759
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-30
Brief Title:
To Compare the Efficacy and Safety of Using oXiris and M100 During CRRT
Sponsor:
Mohd Zulfakar Mazlan MBBS
Organization:
Universiti Sains Malaysia
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 500ml24H 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
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 500ml24H 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None