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

This study has been completed.
Sponsor:
Information provided by:
Renal Research Institute
ClinicalTrials.gov Identifier:
NCT00618033
First received: February 4, 2008
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Hemodialysis
ESRD
 Procedure: Hemodialysis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Short-Term Study of Physiologic Dialysate Glucose Concentration in Chronic Hemodialysis Patients

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Fatigue
Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Renal Research Institute:

Primary Outcome Measures:
  • Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: February 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Procedure: Hemodialysis
varying concentration of glucose in dialysate
Active Comparator: 2 Procedure: Hemodialysis
varying concentration of glucose in dialysate

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618033

Locations
United States, New York
Yorkville Dialysis Center
New York, New York, United States, 10128
Irving Place Dialysis Center
New York, New York, United States, 10003
Sponsors and Collaborators
Renal Research Institute
Investigators
Principal Investigator: Nathan W. Levin, MD Renal Research Institute
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nathan Levin, MD, Renal Research Institute
ClinicalTrials.gov Identifier: NCT00618033     History of Changes
Other Study ID Numbers: 169-07
Study First Received: February 4, 2008
Last Updated: June 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Renal Research Institute:
Hemodialysis
ESRD

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013