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

Not Applicable

Completed

• Conditions: Hemodialysis Complication; Covid19; Inflammatory Response

• Registration Number: NCT04685447
• Lead Sponsor: Universita degli Studi di Genova

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.

Study Timeline

• Study Start: 2020-03-16
• Primary Completion: 2020-04-20
• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-28
• Status Verified: 2022-05
• Study Completion: 2022-05-01
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• Acute kidney injury

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Ospedale IRCCS San Martino; 🇮🇹 Genova, Italy

Policlinico IRCCS Ospedale San Matteo; 🇮🇹 Pavia, Italy