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NCT Number: NCT04685447

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

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Hemodialysis Complication Infections Inflammation Inflammatory Response Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale IRCCS San Martino, Genova, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Acute kidney injury

Treatment and study plan

Expanded Hemodialysis for Covid19 maintenance hemodialysis patients

Procedure

After Covid19 diagnosis participants are randomized to receive Expanded Hemodialysis for two weeks

Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients

Procedure

After Covid19 diagnosis participants are randomized to receive hemodialysis by protein-leaking dialyzer for two weeks

Primary outcomes

  1. 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

    Time frame: 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

  2. Longitudinal changes of soluble TLR4 (sTLR4) plasma levels during Covid19 in hemodialysis patients

    Time frame: 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 outcomes

  1. 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

    Time frame: Two-week observation period after Covid19 diagnosis

    Lymphocyte and immune cell profiles studied by flow cytometry

Sponsors and collaborators

Lead sponsor

Universita degli Studi di Genova

Other

Collaborators

  • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Dec 28, 2020
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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