Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients

Hemodialysis Clinical Trial

— Dextrose  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00618033
• Other study ID #: 169-07
• Status: Completed
• Phase: N/A
• First received: February 4, 2008
• Last updated: June 8, 2011
• Start date: February 2008
• Est. completion date: August 2008

Study information

• Verified date: June 2011
• Source: Renal Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• ESRD
• Hemodialysis

Intervention

Procedure:
• Hemodialysis
varying concentration of glucose in dialysate

Locations

Country	Name	City	State
United States	Irving Place Dialysis Center	New York	New York
United States	Yorkville Dialysis Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Renal Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

Ferrario M, Raimann JG, Thijssen S, Signorini MG, Kruse A, Diaz-Buxo JA, Cerutti S, Levin NW, Kotanko P. Effects of dialysate glucose concentration on heart rate variability in chronic hemodialysis patients: results of a prospective randomized trial. Kidn — View Citation

Raimann JG, Kruse A, Thijssen S, Kuntsevich V, Diaz-Buxo JA, Levin NW, Kotanko P. Fatigue in hemodialysis patients with and without diabetes: results from a randomized controlled trial of two glucose-containing dialysates. Diabetes Care. 2010 Sep;33(9):e1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment		6 weeks	Yes
Secondary	Intradialytic blood pressure, interdialytic weight gain, serum potassium and phosphorus concentrations, arrhythmias during dialysis and in the early postdialytic period, postdialytic fatigue		6 weeks	Yes