Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hemodialysis, ESRD

Intervention / Treatment
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* Procedure: Hemodialysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Procedure: Hemodialysis<br>* varying concentration of glucose in dialysate<br>|
| Active Comparator: 2<br> | Procedure: Hemodialysis<br>* varying concentration of glucose in dialysate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intradialytic blood pressure, interdialytic weight gain, serum potassium and phosphorus concentrations, arrhythmias during dialysis and in the early postdialytic period, postdialytic fatigue |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, ESRD