NCT00618033

Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients

Short-Term Study of Physiologic Dialysate Glucose Concentration in Chronic Hemodialysis Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Renal Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Hemodialysis
• ESRD

Interventions

Type	Name	Description
PROCEDURE	Hemodialysis	varying concentration of glucose in dialysate

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-02-18
• Last updated: 2011-06-09

Locations

2 sites across 1 country: United States