Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients

Not Applicable

Completed

• Conditions: Hemodialysis; ESRD
• Interventions: Procedure: Hemodialysis

• Registration Number: NCT00618033
• Lead Sponsor: Renal Research Institute

Brief 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

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-18
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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
• Hospitalisations or antibiotics-dependent infection during the 8 weeks preceding enrollment
• Central venous catheter as hemodialysis access

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Hemodialysis	-
2	Hemodialysis	-

Primary Outcome Measures

Name	Time	Method
Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment	6 weeks

Secondary Outcome Measures

Name	Time	Method
Intradialytic blood pressure, interdialytic weight gain, serum potassium and phosphorus concentrations, arrhythmias during dialysis and in the early postdialytic period, postdialytic fatigue	6 weeks

Trial Locations

Locations (2)

Yorkville Dialysis Center; 🇺🇸 New York, New York, United States

Irving Place Dialysis Center; 🇺🇸 New York, New York, United States