Effects of Different Dialysis Strategies on Inflammation in COVID-19 Maintenance Hemodialysis Patients
NCT ID: NCT04685447
Last Updated: 2022-05-17
Study Results
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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COMPLETED
NA
30 participants
INTERVENTIONAL
2020-03-16
2022-05-01
Brief Summary
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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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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Expanded Hemodialysis
Hemodialysis modality performed by using a medium cut-off membrane
Expanded Hemodialysis for Covid19 maintenance hemodialysis patients
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.
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
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
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
Eligibility Criteria
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Inclusion Criteria
* Confirmed severe acute respiratory syndrome-coronavirus2 infection
Exclusion Criteria
18 Years
ALL
No
Sponsors
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IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
OTHER
Universita degli Studi di Genova
OTHER
Responsible Party
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Pasquale Esposito
Professor
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
Policlinico IRCCS Ospedale San Matteo
Pavia, , Italy
Countries
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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.
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.
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.
Other Identifiers
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CER Liguria: 135/20
Identifier Type: -
Identifier Source: org_study_id
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