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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

February 4, 2008
June 8, 2011
February 2008
August 2008   (final data collection date for primary outcome measure)
Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00618033 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients
Short-Term Study of Physiologic Dialysate Glucose Concentration in Chronic 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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Hemodialysis
  • ESRD
Procedure: Hemodialysis
varying concentration of glucose in dialysate
  • Active Comparator: 1
    Intervention: Procedure: Hemodialysis
  • Active Comparator: 2
    Intervention: Procedure: Hemodialysis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00618033
169-07
No
Nathan Levin, MD, Renal Research Institute
Renal Research Institute
Not Provided
Principal Investigator: Nathan W. Levin, MD Renal Research Institute
Renal Research Institute
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP