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

NCT ID: NCT04685447

Last Updated: 2022-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-16

Study Completion Date

2022-05-01

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.

Conditions

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Covid19 Hemodialysis Complication Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Expanded Hemodialysis

Hemodialysis modality performed by using a medium cut-off membrane

Group Type EXPERIMENTAL

Expanded Hemodialysis for Covid19 maintenance hemodialysis patients

Intervention Type PROCEDURE

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

Protein-leaking hemodialysis

Hemodialysis modality performed by using a membrane with accentuated absorption capacities.

Group Type EXPERIMENTAL

Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients

Intervention Type PROCEDURE

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

Interventions

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Expanded Hemodialysis for Covid19 maintenance hemodialysis patients

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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Acute kidney injury
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role collaborator

Universita degli Studi di Genova

OTHER

Sponsor Role lead

Responsible Party

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Pasquale Esposito

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesca Viazzi, MD

Role: STUDY_DIRECTOR

Unit of Nephrology, Dept Internal Medicine, Univerity of Genova and San Martino Hospital

Locations

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Ospedale IRCCS San Martino

Genova, , Italy

Site Status

Policlinico IRCCS Ospedale San Matteo

Pavia, , Italy

Site Status

Countries

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Italy

References

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Esposito P, Russo R, Conti N, Falqui V, Massarino F, Moriero E, Peloso G, Traverso GB, Garibotto G, Viazzi F. Management of COVID-19 in hemodialysis patients: The Genoa experience. Hemodial Int. 2020 Jul;24(3):423-427. doi: 10.1111/hdi.12837. Epub 2020 May 12. No abstract available.

Reference Type BACKGROUND
PMID: 32365278 (View on PubMed)

Russo E, Esposito P, Taramasso L, Magnasco L, Saio M, Briano F, Russo C, Dettori S, Vena A, Di Biagio A, Garibotto G, Bassetti M, Viazzi F; GECOVID working group. Kidney disease and all-cause mortality in patients with COVID-19 hospitalized in Genoa, Northern Italy. J Nephrol. 2021 Feb;34(1):173-183. doi: 10.1007/s40620-020-00875-1. Epub 2020 Oct 6.

Reference Type BACKGROUND
PMID: 33025516 (View on PubMed)

Ma Y, Diao B, Lv X, Zhu J, Chen C, Liu L, Zhang S, Shen B, Wang H. Epidemiological, Clinical, and Immunological Features of a Cluster of COVID-19-Contracted Hemodialysis Patients. Kidney Int Rep. 2020 Jun 9;5(8):1333-1341. doi: 10.1016/j.ekir.2020.06.003. eCollection 2020 Aug.

Reference Type BACKGROUND
PMID: 32775837 (View on PubMed)

Other Identifiers

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CER Liguria: 135/20

Identifier Type: -

Identifier Source: org_study_id

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