Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-08-31

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.

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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

Conditions

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Hemodialysis ESRD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Hemodialysis

Intervention Type PROCEDURE

varying concentration of glucose in dialysate

2

Group Type ACTIVE_COMPARATOR

Hemodialysis

Intervention Type PROCEDURE

varying concentration of glucose in dialysate

Interventions

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Hemodialysis

varying concentration of glucose in dialysate

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No