Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation (pilot OMAGOD +)

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: Hemodialysis Complication; Hemodialysis; Thromboinflammation; End Stage Renal Disease (ESRD)

Treatments: Other: Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L; Other: Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L; Other: Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L

Study type: Interventional

Funder types: Other

Identifiers

NCT07206524

25113_PILOTOMAGOD

Details and patient eligibility

About

This clinical trial investigates whether the composition of dialysate influences hemodialysis-associated thromboinflammation. Specifically, it evaluates the effects of magnesium concentration and acid type in dialysate on immune cell activation and thromboinflammatory responses.

Patients participating to the multicentric pilot OMAGOD trial will be invited to participate to this monocentric plus study.

In the pilot OMAGOD trial, participants will undergo standard hemodialysis (3 sessions/week, 4 hours each) and receive three different dialysate compositions in a crossover design. Each treatment phase lasts two weeks (six sessions).

For the local plus study, during selected sessions (3 per patient - midweek hemodialysis session of the last week of a treatment period), blood samples will be collected (at baseline, hourly, and at the end of dialysis) and additionally, after each session, the used dialysis circuit will be rinsed to recover adherent cells.

The study aims to:

• Assess whether the dialysate composition influences leukocyte and platelet activation .
• Evaluate whether the dialysate composition influences neutrophil extracellular trap (NET) formation.
• Identify novel biomarkers of thromboinflammation using transcriptomic analysis of immune cells.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants to the OMAGOD pilot trial

Exclusion criteria

• Patients who are not participating in the OMAGOD pilot trial

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 3 patient groups

Acetic acid dialysate (0.5 mmol/L Mg)

Active Comparator group

Description:

Standardized hemodialysis treatments 3x4hours/week. Intervention: 2 weeks (six hemodialysis sessions) during which patients will be dialyzed with standard acetate-based dialysate containing 0,5 mmol/L magnesium.

Treatment:

Other: Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L

Citric acid dialysate (Mg 1.0 mmol/L)

Active Comparator group

Description:

Standardized hemodialysis treatments 3x4hours/week. Intervention: 2 weeks (six hemodialysis sessions) using a citric acid dialysate containing magnesium 1.0 mmol/L

Treatment:

Other: Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L

Citric acid dialysate (Mg 0.75 mmol/L)

Active Comparator group

Description:

Standardized hemodialysis treatments 3x4hours/week. Intervention: 2 weeks (six hemodialysis sessions) using a citrate-enriched dialysate containing magnesium 0.75 mmol/L

Treatment:

Other: Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L