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临床试验/NCT06440759
NCT06440759招募中不适用

Evaluation of Efficacy and Safety Using oXiris Versus M100 Filter in Pneumonia-induced Acute Kidney Injury (AKI) Patients Requiring Continuous Renal Replacement Therapy (CRRT)

Mohd Zulfakar Mazlan, MBBS2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
To compare the 28-days mortality of using oxiris filter during CRRT

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

single-blinding (patient)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

To compare the 28-days mortality of using oxiris filter during CRRT

时间窗: 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.

To measure the effectiveness of the oxiris filter in reducing septic biomarker levels IL-6

时间窗: 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

次要结局

  • To measure the effectiveness of the oxiris filter in reducing septic biomarker levels PCT(24 hours)
  • To compare the risk bleeding of using oxiris during CRRT(28 days)
  • To compare the risk infection of by 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 CRP(24 hours)

研究者

发起方
Mohd Zulfakar Mazlan, MBBS
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohd Zulfakar Mazlan, MBBS

Associate Professor

Universiti Sains Malaysia

研究点 (2)

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