Microcirculatory dysfunction and sequestered salt content in dialysis patients
Conditions
Interventions
Participants will be subjected to 5 dialysis treatments in random order:
1. Hemodialysis (HD) with net sodium balance: (Dialysate sodium (DNa)= Plasma
sodium (PNa))
2. HD with net sodium efflux (DN
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >=18 years - Treatment with hemodialysis or hemodiafiltration 3x per week during at least 4 hours for at least 3 months - Blood flow rate feasiblity of >=350 ml/min - Residual diuresis = 1.2 - Ability to understand study procedures and willingness to provide informed consent
Exclusion criteria
Exclusion criteria: - Severe incompliance to dialysis procedure and accompanying prescriptions, especially frequency and duration of dialysis treatment - Life expectancy 10% - Participation in another clinical intervention trial - Metal implants (e.g. implantable cardioverter defibrillators) - Severe obesity (abdominal width >= 188 cm) - Claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The SSC (sequestered sodium content) in muscle, as assessed by 23Na-MRI, after 4 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The predialytic SSC (sequestered sodium content) in the skin, as assessed by 23Na-MRI, after 4 weeks of treatment. - Microcirculation, as assessed by skin perfusion/reactivity, after 4 weeks of treatment - Hemodynamics: peri- and intradialytic blood pressure (BP), BP variability and IDH will be assessed by automatic arm-cuff measurements attached to the dialysis machine (4x per hour). In addition, interdialytic blood pressure will be evaluated. Patients will be asked to measure their blood pressure thrice a day between the second-last and the last dialysis session of each treatment period. - Patient experience: patient reported outcome measures (PROMs) as indicated by the Dialysis Symptom Index and the EQ-5D-5L visual analogue scale and thirst measured by the Thirst Distress Scale. - Markers of cardiac damage measured pre- and post treatment in blood drawn from the arterial line of the extracorporeal circuit - Markers of endothelial damage measured pre- and post treatment in blood drawn from the arterial line of the extracorporeal circuit - Markers of inflammation: high sensitive C-reactive protein (hsCRP), interleukin-6 receptor (IL-6R), soluble CD 163 and soluble intercellular adhesion molecule-1 (sICAM-1) will be measured pre- and post treatment using blood from the arterial line of the extracorporeal circuit. - Markers related to sequestered sodium content: serum glycosaminoglycans, syndecan-1 and vascular endothelial growth factor C (VEGF-C) will be assessed pre- and post treatment using blood from the arterial line of the extracorporeal circuit - Depending on a pilot study, extracellular vesicles as markers for organ damage will be assessed pre- and post treatment using blood from the arterial line of the extracorporeal circuit. | — |
Countries
Netherlands
Outcome results
None listed