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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19, Hemodialysis Complication, Inflammatory Response

Intervention / Treatment
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* Procedure: Expanded Hemodialysis for Covid19 maintenance hemodialysis patients
* Procedure: Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing maintenance hemodialysis Confirmed severe acute respiratory syndrome-coronavirus2 infection Exclusion Criteria: Acute kidney injury

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expanded Hemodialysis<br>Hemodialysis modality performed by using a medium cut-off membrane | Procedure: Expanded Hemodialysis for Covid19 maintenance hemodialysis patients<br>* After Covid19 diagnosis participants are randomized to receive Expanded Hemodialysis for two weeks<br>|
| Experimental: Protein-leaking hemodialysis<br>Hemodialysis modality performed by using a membrane with accentuated absorption capacities. | Procedure: Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients<br>* After Covid19 diagnosis participants are randomized to receive hemodialysis by protein-leaking dialyzer for two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Evaluation of circulating levels of pro and anti-inflammatory cytokines (pg/ml) at different time-points in patients treated with two different dialysis modalities | Two-week observation period after Covid19 diagnosis | 
| Longitudinal changes of soluble TLR4 (sTLR4) plasma levels during Covid19 in hemodialysis patients | Evaluation of circulating levels of soluble TLR4 (sTLR4, ng/ml)at different time-points in patients treated with two different dialysis modalities | Two-week observation period after Covid19 diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Lymphocyte and immune cell profiles studied by flow cytometry | Two-week observation period after Covid19 diagnosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Covid19, Inflammation