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Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00618033
Acronym
Dextrose
Enrollment
30
Registered
2008-02-18
Start date
2008-02-29
Completion date
2008-08-31
Last updated
2011-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESRD, Hemodialysis

Keywords

Hemodialysis, ESRD

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

Interventions

PROCEDUREHemodialysis

varying concentration of glucose in dialysate

Sponsors

Renal Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment6 weeks

Secondary

MeasureTime frame
Intradialytic blood pressure, interdialytic weight gain, serum potassium and phosphorus concentrations, arrhythmias during dialysis and in the early postdialytic period, postdialytic fatigue6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026