Comparison of Two Types of Dialyzers (PMMA vs Polysulfone) on Cytokine Extraction in Hemodialysis Patients and COVID Infection. A Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Percentage of Inflammatory interleukins reduction with two different dialysis membranes (PMMA and PS).
研究概览
简要总结
Controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with COVID-19.
详细描述
Controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with COVID-19.
Patients will be dialysed according to the usual dialysis schedule of three weekly sessions. The study has a duration of 8 days in order to include 4 haemodialysis sessions. The first and third haemodialysis sessions will be dialysed with PS membrane and the second and fourth sessions with PMMA membrane, both dialysers with a surface area of 1.8 m2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years .
- •Patient on chronic haemodialysis admitted to the hospital with a diagnosis of infection by COVID-
- •Signature of informed consent or legal representative.
- •Estimated duration of admission greater than 8 days (4 haemodialysis sessions).
- •Patient with haemodynamic stability, understood as systolic blood pressure ≥ 100 mmHg.
排除标准
- •Refusal to sign the consent form.
- •Patients who for clinical reasons are unable to follow a regular dialysis schedule of three sessions per week.
- •Allergy (documented or suspected) to either of the two membranes involved in the study.
- •Patient with haemodynamic instability (Mean arterial pressure < 100 mmHg).
结局指标
主要结局
Percentage of Inflammatory interleukins reduction with two different dialysis membranes (PMMA and PS).
时间窗: Day 8
To compare the percentage reduction of inflammatory interleukins measured at the beginning and end of haemodialysis in the same patient with COVID 19 infection dialysed with two different dialysis membranes (PMMA and PS).
次要结局
- Percentage of Inflammatory interleukins reduction(Days 5 and 8)
- Inflammatory interleukins reduction (30 minutes)(Days 1,3,5,8)
- Populational characteristics(Day 8)
研究者
Mª Jesús Puchades
MD PhD
Fundación para la Investigación del Hospital Clínico de Valencia