Skip to main content
OpenTrials
Completed

NCT Number: NCT00618033

Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Irving Place Dialysis Center, New York, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hemodialysis

Procedure

varying concentration of glucose in dialysate

Primary outcomes

  1. Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment

    Time frame: 6 weeks

Secondary outcomes

  1. Intradialytic blood pressure, interdialytic weight gain, serum potassium and phosphorus concentrations, arrhythmias during dialysis and in the early postdialytic period, postdialytic fatigue

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Renal Research Institute

Other

Registry information

Official study title

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

Acronym: Dextrose

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 18, 2008
Registry last updated
Jun 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.