ULtrafiltration-Rate Induced CArdiac Strain (ULRICA) - Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUmeå University
About this trial
Patients performing chronic hemodialysis (HD) retain more or less water between dialyses. The water is removed by ultrafiltration and usually during the cleansing of waste products - the HD. The length of HD is usually the same as the time of fluid removal while sometimes this may differ. There is no clear guideline. In previous research the investigator noted that the heart releases more NT-pro-BNP during HD in numerous of the patients.
The present study aims to clarify if the speed of fluid removal during HD is a factor that may alter the release of cardiac markers during HD. If so the recommendations for the prescription of HD can be updated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult HD patients with an intra-dialytic weight gain (IDWG) ≥2.5% of target weight over the long interval (3 days) prior to inclusion.
Patients need to be able to understand the study information
Patients need to be able to give consent.
Disqualifiers
Active systemic inflammatory state such as extensive malignancy or acute septic infection.
Uncontrolled hyperphosphatemia decided by the local routine of the physician (due to somewhat decreased efficacy of the low flux filter to eliminate phosphate)
Trial design
Design model
Crossover
Treatments tested in this trial
Ultrafiltration rate
Procedure/SurgeryFluid removal during HD will be linear. The time on HD for fluid removal is adjusted after a formula for interdialytic weight gain / removal time (see Goto et al 2023).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Standard hemodialysis prescriptionActive comparator 1 intervention
Group B: Modified hemodialysis prescriptionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in NT-pro-BNP (proBNP)
The investigation focuses on the marker for cardiac strain pro-BNP (ng/L). Question: Does the heart get less release of markers for cardiac strain upon a slower speed of fluid removal.
Time frame
Per patient: two dialyses within 8 days; Study period:1 yearSecondary outcomes
1
Change in troponin T
The investigation includes the markers for cardiac strain troponin T (ng/L). Question: Does the heart get less release of markers for cardiac strain upon a slower speed of fluid removal.
Time frame
Per patient: two dialyses within 8 days; Study period:1 year2
Adverse events
The two study dialysis protocols will be analyzed for eventual adverse events.
Time frame
Per patient: two dialyses within 8 days; Study period:1 yearSponsors and contacts
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Source ClinicalTrials.gov