Clinical trial NCT04685447: Effects of Different Dialysis Strategies on Inflammation in COVID-19 Maintenance Hemodialysis Patients
Official title: Inflammatory Cytokine Profile in Maintenance Hemodialysis Patients Affected by COVID-19: Effects of 2 Different Dialysis Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Hemodialysis Complication
Inflammatory Response
Keywords: Hemodialysis
Covid19
Inflammation
Lead sponsor: Universita degli Studi di Genova
Sponsor class: OTHER
Collaborators: name: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
First posted: 2020-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Acute kidney injury

Primary outcomes:
measure: 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
timeFrame: Two-week observation period after Covid19 diagnosis
measure: Longitudinal changes of soluble TLR4 (sTLR4) plasma levels during Covid19 in hemodialysis patients
timeFrame: Two-week observation period after Covid19 diagnosis
Secondary outcomes:
measure: 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
timeFrame: Two-week observation period after Covid19 diagnosis
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Ospedale IRCCS San Martino
city: Pavia
country: Italy
facility: Policlinico IRCCS Ospedale San Matteo
Study officials:
affiliation: Unit of Nephrology, Dept Internal Medicine, Univerity of Genova and San Martino Hospital
name: Francesca Viazzi, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.