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Potassium in Haemodialysis Fluids and Haemodynamics

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ClinicalTrials.gov Identifier: NCT01224314
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : October 20, 2010
Sponsor:
Collaborator:
Fondazione Ettore Balli Locarno
Information provided by:
Ospedale Regionale di Locarno

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Haemodialysis Other: Changing potassium concentration in dialysis fluids Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Haemodynamic Consequences of Changing Potassium Concentrations in Haemodialysis Fluids
Study Start Date : September 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Potassium

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. haemodynamic consequences of dialysate potassium concentration [ Time Frame: 4 weeks ]
    difference in haemodynamic parameters between the extremes in potassium concentration of the dialysate


Secondary Outcome Measures :
  1. incidence of hypotension [ Time Frame: 4 weeks ]
    incidence of hypotension during dialysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224314


Locations
Switzerland
Ospedale Regionale di Locarno
Locarno, Ti, Switzerland, 6600
Sponsors and Collaborators
Ospedale Regionale di Locarno
Fondazione Ettore Balli Locarno
Investigators
Principal Investigator: Luca Gabutti, MD Ospedale Regionale di Locarno
More Information
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Publications:

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
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: October 20, 2010
Last Verified: August 2007

Keywords provided by Ospedale Regionale di Locarno:
Haemodynamics
Hypotension
Potassium
Haemodialysis
Dialysis fluids

Additional relevant MeSH terms:
Dialysis Solutions
Pharmaceutical Solutions