Effects of Different Dialysis Strategies on Inflammation in COVID-19 Maintenance Hemodialysis Patients

University of Genoa (UniGe)

Status: Completed

Conditions: Hemodialysis Complication; Inflammatory Response; Covid19

Treatments: Procedure: Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients; Procedure: Expanded Hemodialysis for Covid19 maintenance hemodialysis patients

Study type: Interventional

Funder types: Other

Identifiers

NCT04685447

CER Liguria: 135/20

Details and patient eligibility

About

In the course of Coronavirus Disease-19 (COVID-19) uncontrolled inflammation has been related to disease severity and unfavorable outcomes.

Here, the investigators study the longitudinal changes of pro- and anti-inflammatory markers in a population of patients undergoing maintenance hemodialysis (HD) affected by COVID-19, evaluating the potential modulating effects of two different dialysis approaches

Full description

For this prospective randomized study, the investigators recruit maintenance hemodialysis patients with confirmed COVID-19 infection. After diagnosis, the patients are randomized to two different dialysis modalities, expanded HD (HDx), performed by use of a medium cut-off membrane, and standard treatment based on the use of a protein-leaking dialyzer (PLD).

The investigators collect clinical and laboratory data, including circulating pre and post-dialysis levels of interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), soluble TLR4 (sTLR4), and interferon-gamma (IFN-g). Samples are collected at diagnosis (T0), and one and two weeks after the diagnosis (T7 and T14, respectively). Moreover, lymphocyte and immune cell profiles are evaluated.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing maintenance hemodialysis
• Confirmed severe acute respiratory syndrome-coronavirus2 infection

Exclusion criteria

• Acute kidney injury

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Expanded Hemodialysis

Experimental group

Description:

Hemodialysis modality performed by using a medium cut-off membrane

Treatment:

Procedure: Expanded Hemodialysis for Covid19 maintenance hemodialysis patients

Protein-leaking hemodialysis

Experimental group

Description:

Hemodialysis modality performed by using a membrane with accentuated absorption capacities.

Treatment:

Procedure: Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients