CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Changing potassium concentration in dialysis fluidsother
Likely dose
Not stated in record
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Search/NCT01224314
NCT01224314N/ACompleted

Haemodynamic Consequences of Changing Potassium Concentrations in Haemodialysis Fluids

Ospedale Regionale di Locarno·interventional·Posted Oct 20, 2010·Updated Oct 20, 2010

In Brief

A clinical study evaluating Changing potassium concentration in dialysis fluids for Haemodialysis. Completed, enrolled 24 participants across 1 site.

Detailed Summary

In a study published in 1995 in the American Journal of Kidney Diseases, Dolson et al demonstrated that a rapid decrease of serum potassium concentrations during haemodialysis would produce a significant increase in systolic blood pressure at the end of the session, even though there were no clear effects on intra-dialytic blood pressure. The authors defined this post-dialysis blood pressure behaviour as "rebound hypertension". Paradoxically, in animal models, other than in the context of end-stage renal disease, potassium is a vasodilator. Considering that the removal of potassium during the haemodialysis session could be theoretically modulated in profiles (as with sodium and bicarbonate), it was deemed suitable to delve deeper into this argument by studying, in detail, the (non invasive) hemodynamic repercussions of changes in the potassium concentration of the dialysate. Not being able to linearly modify the concentration, we decided to divide the dialysis session in 3 tertiles, randomising the patients to all possible dialysate sequences containing the usual concentration of potassium or two cut-off points at +1 and -1 mmol/l. Haemodynamic measurements were performed using a finger beat-to-beat monitor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHaemodialysis
CountriesSwitzerland

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 20, 2010
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.7 years ago

Interventions

Changing potassium concentration in dialysis fluidsother

The dialysis sessions was divided into 3 tertiles, casually modulating potassium concentration in the dialysate between the value normally used K and the two cut-off points K+1 and K-1 mmol/l