The Microcirculation, Dialysis Modality and Sequestered Salt
MIMOSA
1 other identifier
interventional
22
0 countries
N/A
Brief Summary
The aim of this clinical trial is to investigate the effect of 5 different dialysis treatments (combinations of dialysis mode and dialysis fluid sodium content) on the microcirculation (MC) and sequestered sodium content (SSC) in adult prevalent end-stage kidney disease (ESKD) patients treated with hemodialysis (HD) or hemodiafiltration (HDF). The main questions it aims to answer are:
- HDF with an expected zero diffusive sodium balance (Dialysate sodium concentration (DNa)= Plasma sodium concentration (PNa)) compared to
- HDF with an expected diffusive sodium efflux (DNa \< PNa, difference 3 mmol/L) compared to
- HD with an expected zero diffusive sodium balance (DNa = PNa) compared to
- HD with an expected diffusive sodium efflux (DNa \< PNa, difference 3 mmol/L) compared to
- Isolated ultrafiltration for 30 minutes followed by HD with an expected zero diffusive sodium balance (DNa = PNa)
- Are the SSC and MC interrelated in this patient group?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2024
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2024
CompletedFirst Posted
Study publicly available on registry
March 25, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 25, 2024
March 1, 2024
3.5 years
February 21, 2024
March 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Skin microcirculation
Skin microcirculatory perfusion/vasoreactivity (arbitrary units) measured with a laser speckle contrast analysis (LASCA) perfusion imager
up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)
Sequestered salt content (SSC)
SSC measured with a 7 Tesla 23-Sodium MRI
up to 20 weeks; assessed every 4 weeks before the last dialysis session of each treatment period (i.e. 5 times in total)
Secondary Outcomes (17)
Intradialytic hypotension
up to 4 hours (=one dialysis treatment); assessed during all dialysis sessions (12 treatments per intervention, measured 4x/hour)
Change in intradialytic blood pressure
up to 4 hours (=one dialysis treatment); assessed during all dialysis sessions (12 treatments per intervention, measured 4x/hour)
Peridialytic blood pressure
up to 24 hours (=one interdialytic day): measured 3x/day every 4 weeks during the last interdialytic day of each treatment period (i.e. 5 times in total)
Change in CK-MB
up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
Change in high sensitivity C-reactive protein (hs-CRP)
up to 4 hours (=one dialysis treatment); measured before and immediately after the last dialysis session of each treatment period (i.e. 10 times in total)
- +12 more secondary outcomes
Study Arms (5)
Hemodialysis (DNa=PNa)
ACTIVE COMPARATORHigh-flux hemodialysis with expected diffusive zero sodium balance (DNa=PNa)
Hemodialysis (DNa<PNa)
ACTIVE COMPARATORHigh-flux hemodialysis with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L)
Hemodialysis after isolated ultrafiltration (DNa=PNa)
ACTIVE COMPARATORHigh-flux hemodialysis after isolated ultrafiltration with expected zero sodium balance (DNa=PNa)
High volume hemodiafiltration (DNa=PNa)
ACTIVE COMPARATORHigh volume hemodiafiltration with expected diffusive zero sodium balance (DNa=PNa)
High volume hemodiafiltration (DNa<PNa)
ACTIVE COMPARATORHigh volume hemodiafiltration with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L)
Interventions
High-flux hemodialysis with an expected zero diffusive sodium balance (DNa = PNa)
High-flux hemodialysis with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L)
High-flux hemodialysis after isolated ultrafiltration with an expected zero diffusive sodium balance (DNa=PNa)
High volume hemodiafiltration with expected diffusive sodium efflux (DNa\<PNa, difference: 3 mmol/L) Convection volume: ≥23L/session
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- Treatment with HD or HDF 3 x per week during at least 4 hours for at least 3 months
- Blood flow rate feasiblity of ≥350 ml/min
- Residual diuresis \<200 ml/day
- Plasma Na before dialysis 137-145 mmol/L at baseline
- spKt/Vurea ≥ 1.2
- Ability to understand study procedures and willingness to provide informed consent
You may not qualify if:
- Severe incompliance to dialysis procedure and accompanying prescriptions, especially frequency and duration of dialysis treatment
- Life expectancy \< 3 months due to non-renal disease
- Expected transplantation within 6 months
- Access recirculation \> 10%
- Participation in another clinical intervention trial
- Metal implants (e.g. implantable cardioverter defibrillators)
- Severe obesity (MRI Ø 60 cm ≈ abdominal circumference ≤ 188 cm)
- Claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amsterdam UMC, location VUmclead
- Dutch Kidney Foundationcollaborator
- Niercentrum aan de Amstelcollaborator
- B.Braun Avitum AGcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muriel PC Grooteman, MD PhD
Amsterdam UMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Internist-Nephrologist
Study Record Dates
First Submitted
February 21, 2024
First Posted
March 25, 2024
Study Start
June 1, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 25, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share