An interventional study of Hemodialysis in Hemodialysis and ESRD, sponsored by Renal Research Institute. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-09.
Sponsored by Renal Research Institute · Not applicable, Interventional, and Treatment
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
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's enrollment of 30 is below the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Renal Research Institute is the lead sponsor of 19 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Procedure: Hemodialysis
Procedure: Hemodialysis
varying concentration of glucose in dialysate
Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment
Time frame: 6 weeks
Intradialytic blood pressure, interdialytic weight gain, serum potassium and phosphorus concentrations, arrhythmias during dialysis and in the early postdialytic period, postdialytic fatigue
Time frame: 6 weeks
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Renal Research Institute