Covid19, Hemodialysis Complication, Inflammatory Response
Conditions
Keywords
Hemodialysis, Covid19, Inflammation
Brief 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.
Interventions
PROCEDUREExpanded Hemodialysis for Covid19 maintenance hemodialysis patients
After Covid19 diagnosis participants are randomized to receive Expanded Hemodialysis for two weeks
PROCEDUREHemodialysis 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
Sponsors
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Universita degli Studi di Genova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing maintenance hemodialysis * Confirmed severe acute respiratory syndrome-coronavirus2 infection
Exclusion criteria
* Acute kidney injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal changes of interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), and interferon-gamma (IFN-γ) plasma levels during Covid19 in hemodialysis patients | Two-week observation period after Covid19 diagnosis | Evaluation of circulating levels of pro and anti-inflammatory cytokines (pg/ml) at different time-points in patients treated with two different dialysis modalities |
| Longitudinal changes of soluble TLR4 (sTLR4) plasma levels during Covid19 in hemodialysis patients | Two-week observation period after Covid19 diagnosis | Evaluation of circulating levels of soluble TLR4 (sTLR4, ng/ml)at different time-points in patients treated with two different dialysis modalities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal changes of cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), cluster of differentiation 19 (CD19), natural killer (NK) lymphocyte count and function during Covid19 in hemodialysis patients | Two-week observation period after Covid19 diagnosis | Lymphocyte and immune cell profiles studied by flow cytometry |
Countries
Italy
Outcome results
None listed