Potassium in Haemodialysis Fluids and Haemodynamics
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Haemodialysis |
Other: Changing potassium concentration in dialysis fluids |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Haemodynamic Consequences of Changing Potassium Concentrations in Haemodialysis Fluids |
- haemodynamic consequences of dialysate potassium concentration [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]difference in haemodynamic parameters between the extremes in potassium concentration of the dialysate
- incidence of hypotension [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]incidence of hypotension during dialysis
| Enrollment: | 24 |
| Study Start Date: | September 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: dialysis fluid potassium high
potassium concentration in the dialysis fluid 1 mmol/L higher than usual
|
Other: Changing potassium concentration in dialysis fluids
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
Other Name: Potassium concentrations in haemodialysis fluids
|
|
Active Comparator: dialysis fluid potassium low
potassium concentration in the dialysis fluid 1 mmol/L lower than usual
|
Other: Changing potassium concentration in dialysis fluids
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
Other Name: Potassium concentrations in haemodialysis fluids
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- chronic haemodialysis patients
- dialysed 3 to 4 hours three times a week
- clinically stable and without intercurrent illnesses
Exclusion Criteria:
- intercurrent illnesses
Contacts and Locations| Switzerland | |
| Ospedale Regionale di Locarno | |
| Locarno, Ti, Switzerland, 6600 | |
| Principal Investigator: | Luca Gabutti, MD | Ospedale Regionale di Locarno |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Luca Gabutti MD, Division of Nephrology, Ospedale la Carità, Via Ospedale, 6600 Locarno,Switzerland |
| ClinicalTrials.gov Identifier: | NCT01224314 History of Changes |
| Other Study ID Numbers: | 010010 |
| Study First Received: | October 19, 2010 |
| Last Updated: | October 19, 2010 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Ospedale Regionale di Locarno:
|
Haemodynamics Hypotension Potassium Haemodialysis Dialysis fluids |
ClinicalTrials.gov processed this record on May 21, 2013