Comparison of Two Types of Dialyzers (PMMA vs Polysulfone) on Cytokine Extraction in Hemodialysis Patients and COVID Infection. A Multicenter Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Percentage of Inflammatory interleukins reduction with two different dialysis membranes (PMMA and PS).
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Percentage of Inflammatory interleukins reduction with two different dialysis membranes (PMMA and PS).
Time Frame: 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).
Secondary Outcomes
- Percentage of Inflammatory interleukins reduction(Days 5 and 8)
- Inflammatory interleukins reduction (30 minutes)(Days 1,3,5,8)
- Populational characteristics(Day 8)
Investigators
Mª Jesús Puchades
MD PhD
Fundación para la Investigación del Hospital Clínico de Valencia