Effects of Different Dialysis Strategies on Inflammation in COVID-19 Maintenance Hemodialysis Patients
Primary Purpose
Covid19, Hemodialysis Complication, Inflammatory Response
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Expanded Hemodialysis for Covid19 maintenance hemodialysis patients
Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients
Sponsored by
About this trial
This is an interventional other trial for Covid19 focused on measuring Hemodialysis, Covid19, Inflammation
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing maintenance hemodialysis
- Confirmed severe acute respiratory syndrome-coronavirus2 infection
Exclusion Criteria:
- Acute kidney injury
Sites / Locations
- Ospedale IRCCS San Martino
- Policlinico IRCCS Ospedale San Matteo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Expanded Hemodialysis
Protein-leaking hemodialysis
Arm Description
Hemodialysis modality performed by using a medium cut-off membrane
Hemodialysis modality performed by using a membrane with accentuated absorption capacities.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04685447
First Posted
December 22, 2020
Last Updated
May 16, 2022
Sponsor
Universita degli Studi di Genova
Collaborators
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
1. Study Identification
Unique Protocol Identification Number
NCT04685447
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
April 20, 2020 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita degli Studi di Genova
Collaborators
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Hemodialysis Complication, Inflammatory Response
Keywords
Hemodialysis, Covid19, Inflammation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Expanded Hemodialysis
Arm Type
Experimental
Arm Description
Hemodialysis modality performed by using a medium cut-off membrane
Arm Title
Protein-leaking hemodialysis
Arm Type
Experimental
Arm Description
Hemodialysis modality performed by using a membrane with accentuated absorption capacities.
Intervention Type
Procedure
Intervention Name(s)
Expanded Hemodialysis for Covid19 maintenance hemodialysis patients
Intervention Description
After Covid19 diagnosis participants are randomized to receive Expanded Hemodialysis for two weeks
Intervention Type
Procedure
Intervention Name(s)
Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients
Intervention Description
After Covid19 diagnosis participants are randomized to receive hemodialysis by protein-leaking dialyzer for two weeks
Primary Outcome Measure Information:
Title
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
Description
Evaluation of circulating levels of pro and anti-inflammatory cytokines (pg/ml) at different time-points in patients treated with two different dialysis modalities
Time Frame
Two-week observation period after Covid19 diagnosis
Title
Longitudinal changes of soluble TLR4 (sTLR4) plasma levels during Covid19 in hemodialysis patients
Description
Evaluation of circulating levels of soluble TLR4 (sTLR4, ng/ml)at different time-points in patients treated with two different dialysis modalities
Time Frame
Two-week observation period after Covid19 diagnosis
Secondary Outcome Measure Information:
Title
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
Description
Lymphocyte and immune cell profiles studied by flow cytometry
Time Frame
Two-week observation period after Covid19 diagnosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing maintenance hemodialysis
Confirmed severe acute respiratory syndrome-coronavirus2 infection
Exclusion Criteria:
Acute kidney injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesca Viazzi, MD
Organizational Affiliation
Unit of Nephrology, Dept Internal Medicine, Univerity of Genova and San Martino Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ospedale IRCCS San Martino
City
Genova
Country
Italy
Facility Name
Policlinico IRCCS Ospedale San Matteo
City
Pavia
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32365278
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.
Results Reference
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PubMed Identifier
33025516
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.
Results Reference
background
PubMed Identifier
32775837
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.
Results Reference
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Effects of Different Dialysis Strategies on Inflammation in COVID-19 Maintenance Hemodialysis Patients
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