Hemodialysis Clinical Trial
Official title:
Short-Term Study of Physiologic Dialysate Glucose Concentration in Chronic Hemodialysis Patients
This study aims to show that using a glucose (sugar) concentration of 100 mg/dL in the dialysis fluid for hemodialysis is not inferior to using a concentration of 200 mg/dL with regard to the frequency and magnitude of blood glucose drops. Other parameters that will be compared between the two groups are blood pressure, heart rhythm, weight gain between dialysis treatments, and fatigue after the treatment.
This is a prospective, randomized, single-blinded cross-over non-inferiority trial of intra-
and early post-dialytic glucose homeostasis comparing 100 mg/dL against 200 mg/dL dialysate
glucose concentration in 30 hemodialysis patients. The primary outcome is the frequency and
magnitude of hypoglycemia during and early after the hemodialysis treatment. Secondary
outcomes include intradialytic blood pressure, interdialytic weight gain, serum potassium
and phosphorus concentrations, arrhythmias during dialysis and in the early postdialytic
period, and postdialytic fatigue.
Inclusion criteria:
Age ≥ 18 years
Maintenance hemodialysis with hemodialysis vintage of at least 30 days
Ability to read and understand the English language and give informed consent
Exclusion criteria:
Dialysis treatment frequencies other than three times per week
Hospitalizations or antibiotics-dependent infection during the 8 weeks preceding enrollment
Central venous catheter as hemodialysis access
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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