Clinical trial NCT00618033: Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients
Official title: Short-Term Study of Physiologic Dialysate Glucose Concentration in Chronic Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
ESRD
Keywords: Hemodialysis
ESRD
Lead sponsor: Renal Research Institute
Sponsor class: OTHER
First posted: 2008-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Intradialytic blood pressure, interdialytic weight gain, serum potassium and phosphorus concentrations, arrhythmias during dialysis and in the early postdialytic period, postdialytic fatigue
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Irving Place Dialysis Center
state: New York
city: New York
country: United States
facility: Yorkville Dialysis Center
state: New York
Study officials:
affiliation: Renal Research Institute
name: Nathan W. Levin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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):e121. doi: 10.2337/dc10-1043. No abstract available.
citation: 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. Kidney Blood Press Res. 2011;34(5):334-43. doi: 10.1159/000327851. Epub 2011 May 25.
citation: Raimann JG, Kruse A, Thijssen S, Kuntsevich V, Dabel P, Bachar M, Diaz-Buxo JA, Levin NW, Kotanko P. Metabolic effects of dialyzate glucose in chronic hemodialysis: results from a prospective, randomized crossover trial. Nephrol Dial Transplant. 2012 Apr;27(4):1559-68. doi: 10.1093/ndt/gfr520. Epub 2011 Sep 22.