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临床试验/NCT03489759
NCT03489759Unknown不适用

The Effect of Vitamin E-coated Polysulfone Membrane on Oxidative Stress, Inflammation and Monocytes in Critically Ill Patients in CRRT: a Pilot, Randomized, Double-blinded, No-profit, Clinical Study

St. Bortolo Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Copper/Zinc

研究概览

简要总结

The study evaluate the effect of a membrane in polysulfone covered with vitamin E (ViE15-A, ASAHI Kasey, Tokyo, Japan) versus non-vitamin E polysulfone membrane (REXEED-15A, ASAHI Kasey, Tokyo, Japan) in critically ill patients admitted to intensive care undergoing continuous extracorporeal dialysis (CRRT).

The current randomized study is designed to assess the effect on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines using ViE 15-A in comparison withe REXEED-15A.

The investigators hypothezise that the ViE15-A versus REXEED-15A will have different effect on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines.

详细描述

The study evaluate the effect of a membrane in polysulfone covered with vitamin E (ViE15-A, ASAHI Kasey, Tokyo, Japan) on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines in critically ill patients admitted to intensive care undergoing continuous extracorporeal dialysis (CRRT).

This membrane will be compared with a non-vitamin E polysulfone membrane (REXEED-15A, ASAHI Kasey, Tokyo, Japan) and already intended for use in continuous renal support therapy.

The current randomized study is designed to assess the effect on the levels of oxidative stress, pro and anti-inflammatory cytokines and the mode and amount of death of monocytic cell lines using ViE 15-A in comparison withe REXEED-15A.

Precisely, will be evaluated

  1. the effect of the filter on the reduction of the plasma levels of two pro-inflammatory cytokines (IL-1β and IL-6) and of two anti-inflammatory cytokines (IL-10, IL-8);
  2. the analysis of the life modality of the monocytic cells: the patient's plasma will be used, incubated for 24 hours with U937 cells (monocyte precursor cells), necrosis cells and the percentage of apoptotic cells. The apoptotic cells will also evaluate the apoptotic pathway (evaluation of activated caspases) that led to cell death. The differences that are highlighted in the two different sampling moments become expressed Δ% with respect to the initial value Secondary outcomes will be to evaluate the clinical outcomes (haemodynamic and hematochemical parameters) in the short and long term deriving from the application of a membrane with vitamin E; for this reason, for the whole duration of the extracorporeal dialysis therapy, the same filter assigned to the patient at the time of enrollment will be used.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The randomization list will be kept in a special lockable closet, not accessible to the other investigators involved in the study. The one who will create the list will not be involved in any other role in the present study.

The filter label, and hence the name, will be covered by a white covering label. Each kit of filters needed to perform a single treatment will be prepared in a closed box and the patient number will be written on it, so that the user who performs the treatment will not be able to understand which filter it is.

All the other investigators involved in the present study (nurses in the Nephrology department who will follow the treatment, the researchers who will collect the clinical data, the biologists who will analyze the samples and the statisticians who will analyze the data) will not know which filter has been applied in each treatment.

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

  • Age > 18 years
  • Acute Kidney Injury
  • ICU patients with clinical indication for Continuous Renal Replacement Therapy
  • Clinical decision to begin CVVH for at least 24 hours with high flux filter (defined as membranes with an ultrafiltration coefficient KUF > 25ml/Kg/h)
  • Obtain the informed consent

排除标准

  • Hemodialysis patients, peritoneal dialysis patients and transplant recipient;
  • Hypothermia (T < 36°C)
  • Regional Anticoagulation with Citrate
  • Septic Shock;
  • Neoplasm in Chemotherapy
  • Extra-Corporeal Membrane Oxygenation
  • Cardio Circulatory Arrest
  • Autoimmune disease or immunosuppressed patients;
  • Life expectancy < 24 hr
  • Pregnancy;
  • Informed Consent refused by the patient or surrogate decision-maker

研究组 & 干预措施

ViE15-A

Experimental

The patients were randomly allocated to two groups by using computer-generated numbers. The renal replacement therapy will be started using ViE15-A hemofilter

干预措施: ViE15-A (Device)

REXEED-15A

Active Comparator

TThe patients were randomly allocated to two groups by using computer-generated numbers. The renal replacement therapy will be started using REXEED-15A

干预措施: REXEED-15A (Device)

结局指标

主要结局

Copper/Zinc

时间窗: change from 24 to 72 hours

In vivo comparison of ROS concentrations in two groups

Viability

时间窗: change from 24 to 72 hours

Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma

Endogenous peroxidase activity

时间窗: change from 24 to 72 hours

In vivo comparison of ROS concentrations in two groups

Necrosis

时间窗: change from 24 to 72 hours

Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma

Interleukine -10

时间窗: change from 24 to 72 hours

In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups

Interleukine-18

时间窗: change from 24 to 72 hours

In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups

Superoxide Dismutas

时间窗: change from 24 to 72 hours

In vivo comparison of ROS concentrations in two groups

Apoptosis

时间窗: change from 24 to 72 hours

Ex vivo comparison of relative decrease of monocytes cell line incubated in plasma

Nitric Oxide

时间窗: change from 24 to 72 hours

In vivo comparison of ROS concentrations in two groups

Interleukine-6

时间窗: change from 24 to 72 hours

In vivo comparison of relative reductions of inflammatory cytokines concentrations in two groups

次要结局

  • Comparison of mechanical Ventilation-free days from enrollment to ICU discharge in two groups(7 days)
  • Comparison of ICU length of stay in two groups(7 days)
  • Comparison of renal recovery in two groups(7 days)
  • Comparison of need of (Intermittent Hemodialysis) IHD at hospital discarge in patients treated with vitamine E-coated membrane and non-vitamin E-coated membrane(90 days)
  • Comparison of CRRT-free days from enrollment to ICU discharge in two groups(7 days)
  • Comparison of renal recovery at hospital discharge in two groups(90 days)
  • Comparison of vasopressor drugs-free days in two groups(7 days)
  • Comparison of CRRT-free days from enrollment to hospital discharge in two groups(90 days)

研究者

发起方
St. Bortolo Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia De Rosa

Medical Doctor

St. Bortolo Hospital

研究点 (2)

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