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

May 16, 2022 updated by: Pasquale Esposito, Universita degli Studi di Genova

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genova, Italy
        • Ospedale IRCCS San Martino
      • Pavia, Italy
        • Policlinico IRCCS Ospedale San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute kidney injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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
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
Two-week observation period after Covid19 diagnosis
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
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
Time Frame: Two-week observation period after Covid19 diagnosis
Lymphocyte and immune cell profiles studied by flow cytometry
Two-week observation period after Covid19 diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita degli Studi di Genova

Collaborators

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

Investigators

  • Study Director: Francesca Viazzi, MD, Unit of Nephrology, Dept Internal Medicine, Univerity of Genova and San Martino Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2020

Primary Completion (Actual)

April 20, 2020

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER Liguria: 135/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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