SARS-CoV-2 Infection
Conditions
Keywords
Haemodialysis, SARS-CoV-2 Infection, cytokines
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.
Interventions
DEVICEPS membrane versus PMMA membrane,
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.
Sponsors
Fundación para la Investigación del Hospital Clínico de Valencia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years . * Patient on chronic haemodialysis admitted to the hospital with a diagnosis of infection by COVID-19. * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Inflammatory interleukins reduction with two different dialysis membranes (PMMA and PS). | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Inflammatory interleukins reduction | Days 5 and 8 | Inflammatory interleukins reduction maintenance with each membrane after a second dialysis |
| Inflammatory interleukins reduction (30 minutes) | Days 1,3,5,8 | Inflammatory interleukins percentage reduction 30 min after each session, |
| Populational characteristics | Day 8 | To describe the characteristics of haemodialysis population affected by COVID -19 |
Countries
Spain
Outcome results
None listed