NCT04685447

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

Inflammatory Cytokine Profile in Maintenance Hemodialysis Patients Affected by COVID-19: Effects of 2 Different Dialysis Strategies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Universita degli Studi di Genova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Covid19
• Hemodialysis Complication
• Inflammatory Response

Interventions

Type	Name	Description
PROCEDURE	Expanded Hemodialysis for Covid19 maintenance hemodialysis patients	After Covid19 diagnosis participants are randomized to receive Expanded Hemodialysis for two weeks
PROCEDURE	Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients	After Covid19 diagnosis participants are randomized to receive hemodialysis by protein-leaking dialyzer for two weeks

Timeline

• Start date: 2020-03-16
• Primary completion: 2020-04-20
• Completion: 2022-05-01
• First posted: 2020-12-28
• Last updated: 2022-05-17

Locations

2 sites across 1 country: Italy