Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients — Dextrose  

Hemodialysis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ESRD
• Hemodialysis

• NCT number: NCT00618033
• Study type: Interventional
• Source: Renal Research Institute
• Status: Completed
• Phase: N/A
• Start date: February 2008
• Completion date: August 2008