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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04685447
• Other study ID #: CER Liguria: 135/20
• Status: Completed
• Phase: N/A
• Start date: March 16, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: Universita degli Studi di Genova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 1, 2022
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing maintenance hemodialysis

• Confirmed severe acute respiratory syndrome-coronavirus2 infection

Exclusion Criteria:

• Acute kidney injury

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Hemodialysis Complication
• Inflammatory Response

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Italy	Ospedale IRCCS San Martino	Genova
Italy	Policlinico IRCCS Ospedale San Matteo	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
Universita degli Studi di Genova	IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal changes of interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), and interferon-gamma (IFN-?) plasma levels during Covid19 in hemodialysis patients	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
Primary	Longitudinal changes of soluble TLR4 (sTLR4) plasma levels during Covid19 in hemodialysis patients	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	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	Lymphocyte and immune cell profiles studied by flow cytometry	Two-week observation period after Covid19 diagnosis