Toxins Removal and Inflammatory State modulAtion During Online Hemodiafiltration: Comparison of Two Different Dialyzers

NCT04554498 | Unknown DMC

• 1 other identifier: 596/2019/Oss/AOUBo
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of the study is to evaluate in patients on three times a week on-line HDF the efficacy, in terms of toxin removal and modulation of the inflammatory state, of two different dialyzers: Helixone versus Asimmetric cellulose triacetate (ATA).

Conditions

Hemodialysis Complication; Inflammation; Uremic; Toxemia

Outcome Measures

Primary Outcomes (1)

• Measurement of uremic toxins

  Beta 2 microglobulin (B2M), C-reactive protein (CRP), albumin, myoglobin, light chains, retinol binding protein, homocysteine, p-cresol, indoxyl sulfate, BPA, alpha-2-macroglobulin (A2M), FGF23 (fibroblast growth factor 23)

  24 months. Blood samples will be drawn at Time 0 (on starting the study when the patients starts HDF treatment), after 1 month, after 3 months, after 6 months, after 12 months, and after 24 months (study end)

Secondary Outcomes (8)

• Measurement of endothelial cells metabolism

  24 months. Blood samples will be drawn at Time 0 (on starting the study when the patients starts HDF treatment), after 1 month, after 3 months, after 6 months, after 12 months, and after 24 months (study end)

• Patients survival

  24 months

• Body impedance analysis

  24 months.

• AGEs measurements

  24 months

• Measurement of inflammatory cytokines

  24 months. Blood samples will be drawn at Time 0 (on starting the study when the patients starts HDF treatment), after 1 month, after 3 months, after 6 months, after 12 months, and after 24 months (study end)

Study Arms (2)

Hemodiafiltration with ATA filter

EXPERIMENTAL

patients with clinical history of hypersensitivity to polisulfone/poliethersulfone dialysis filters or hypersensitivity to drugs or generic allergens.

Device: 1) high flux hemodiafiltration thrice -weekly during a 24 month follow-up

Hemodiafiltration with Helixone filter

ACTIVE COMPARATOR

no history of hypersensitivity to polisulfone/poliethersulfone dialysis filters is assessed; no history of hypersensitivity to drugs or generic allergens is assessed.

Device: 1) high flux hemodiafiltration thrice -weekly during a 24 month follow-up

Interventions

1) high flux hemodiafiltration thrice -weekly during a 24 month follow-up DEVICE

1. the comparison of the effects of the two membranes on the serum levels of albumin, B2M, CRP, myoglobin, light chains, retinol binding protein, homocysteine, p-cresol, indoxyl sulfate, BPA, alpha-1-microglobulin (A1M), FGF23 (fibroblast growth factor 23), and inflammatory cytokines; 2. the evaluation of the changes induced by the two filters on lymphocyte subsets, monocyte activation and senescence, and apoptosis rate; 3. the definition of the impact of the two membranes on the accumulation of AGEs as an index of metabolic and oxidative stress, determined by a non-invasive method based on the measurement of skin autofluorescence through a dedicated device (AGE Reader, DiagnOptics Technologies BV, Groningen, Netherlands).

Also known as: 2) assessment of uremic toxins, inflammation and effects of patients sera in culture of endothelial cells, 3) Body impedance analysis by means of Electro fluid graph (EFG®, Akern, Pontassieve, Italia), 4) Measurement of AGEs accumulation through skin autofluorescence. (AGE Reader, DiagnOptics Technologies BV)

Hemodiafiltration with ATA filter; Hemodiafiltration with Helixone filter

Eligibility Criteria

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

You may qualify if:

• Patients with chronic renal failure under periodic standard bicarbonate hemodialysis;
• Three times a week dialysis session;
• Residual diuresis \<200 mL/day;
• Age \>18 years;
• Vascular access for hemodialysis with blood flow \>250 mL/minute;
• Need of on-line hemodiafiltration (HDF) for signs of middle molecules intoxication (e.g. B2M \>30 mg/L, peripheral neuropathy, cardiovascular comorbidities) or for intradialytic hypotension.

You may not qualify if:

• Acute coronary syndrome;
• Acute hemorrage;
• Enrollment in another study protocol;
• Active infection;
• Malignancy;
• Inability to provide written signed consent to participate in the study.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• University of Bologna: collaborator

Study Sites (1)

Nephrology Dialysis and Renal Transplantatio Unit, StOrsola University Hospital

Bologna, 40138, Italy

Location

Related Publications (22)

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• Wang CC, Wang YC, Wang GJ, Shen MY, Chang YL, Liou SY, Chen HC, Chang CT. Skin Autofluorescence Is Associated with Endothelial Dysfunction in Uremic Subjects on Hemodialysis. PLoS One. 2016 Jan 25;11(1):e0147771. doi: 10.1371/journal.pone.0147771. eCollection 2016.

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MeSH Terms

Conditions

Inflammation; Toxemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Gaetano La Manna, Prof

  StOrsola University Hospital, Bologna, Italy

  STUDY DIRECTOR

Central Study Contacts

Gaetano La Manna

CONTACT

+390512144577; gaetano.lamanna@unibo.it

Study Design

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

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: September 18, 2020
• Study Start: January 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

IT (1)