PMMA vs Polysulfone in SARS-CoV-2 Infection Hemodialysis Patients

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.

Official Title
-----------------
Comparison of Two Types of Dialyzers (PMMA vs Polysulfone) on Cytokine Extraction in Hemodialysis Patients and COVID Infection. A Multicenter Prospective Study

Conditions
-----------------
SARS-CoV-2 Infection

Intervention / Treatment
-----------------
* Device: PS membrane versus PMMA membrane,


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm<br>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. | Device: PS membrane versus PMMA membrane,<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Inflammatory interleukins reduction with two different dialysis membranes (PMMA and PS). | 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). | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Inflammatory interleukins reduction | Inflammatory interleukins reduction maintenance with each membrane after a second dialysis | Days 5 and 8 | 
| Inflammatory interleukins reduction (30 minutes) | Inflammatory interleukins percentage reduction 30 min after each session, | Days 1,3,5,8 | 
| Populational characteristics | To describe the characteristics of haemodialysis population affected by COVID -19 | Day 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemodialysis, SARS-CoV-2 Infection, cytokines