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Potassium in Haemodialysis Fluids and Haemodynamics

This study has been completed.
Sponsor:
Collaborator:
Fondazione Ettore Balli Locarno
Information provided by:
Ospedale Regionale di Locarno
ClinicalTrials.gov Identifier:
NCT01224314
First received: October 19, 2010
Last updated: NA
Last verified: August 2007
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Ospedale Regionale di Locarno:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

Additional relevant MeSH terms:
Dialysis Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014