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

Fundación para la Investigación del Hospital Clínico de Valencia12 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

SARS-CoV-2 Infection

Interventions

PS membrane versus PMMA membrane,DEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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).

Locations (1)

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Outcomes

Primary Outcomes

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).

Time frame: Day 8

Secondary Outcomes

Percentage of Inflammatory interleukins reduction

Inflammatory interleukins reduction maintenance with each membrane after a second dialysis

Time frame: Days 5 and 8

Inflammatory interleukins reduction (30 minutes)

Inflammatory interleukins percentage reduction 30 min after each session,

Time frame: Days 1,3,5,8

Populational characteristics

To describe the characteristics of haemodialysis population affected by COVID -19

Time frame: Day 8

Data from ClinicalTrials.gov

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