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

NCT04685447 | Completed

• 1 other identifier: CER Liguria: 135/20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Covid19; Hemodialysis Complication; Inflammatory Response

Keywords

Hemodialysis; Covid19; Inflammation

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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 Outcomes (1)

• 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

  Two-week observation period after Covid19 diagnosis

Study Arms (2)

Expanded Hemodialysis

EXPERIMENTAL

Hemodialysis modality performed by using a medium cut-off membrane

Procedure: Expanded Hemodialysis for Covid19 maintenance hemodialysis patients

Protein-leaking hemodialysis

EXPERIMENTAL

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

Procedure: Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients

Interventions

Expanded Hemodialysis for Covid19 maintenance hemodialysis patients PROCEDURE

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

Expanded Hemodialysis

Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients PROCEDURE

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

Protein-leaking hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Acute kidney injury

Sponsors & Collaborators

• Universita degli Studi di Genova: lead
• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy: collaborator

Study Sites (2)

Ospedale IRCCS San Martino

Genova, Italy

Location

Policlinico IRCCS Ospedale San Matteo

Pavia, Italy

Location

Related 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. No abstract available.

  PMID: 32365278 BACKGROUND

• 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.

  PMID: 33025516 BACKGROUND

• 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.

  PMID: 32775837 BACKGROUND

MeSH Terms

Conditions

COVID-19; Inflammation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesca Viazzi, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: March 16, 2020
• Primary Completion: April 20, 2020
• Study Completion: May 1, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)