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Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients (Dextrose)

R

Renal Research Institute

Status

Completed

Conditions

Hemodialysis
ESRD

Treatments

Procedure: Hemodialysis

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

30 participants in 2 patient groups

1
Active Comparator group
Treatment:
Procedure: Hemodialysis
2
Active Comparator group
Treatment:
Procedure: Hemodialysis

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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