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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemodialysis | Procedure | varying concentration of glucose in dialysate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment | 6 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan W. Levin, MD | Renal Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irving Place Dialysis Center | New York | New York | 10003 | United States | ||
| Yorkville Dialysis Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20805263 | Result | 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. | |
| 21613795 | Result |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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| New York |
| New York |
| 10128 |
| United States |
| 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. |
| 37651553 | Derived | Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2. |
| 21940484 | Derived | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |