Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Renal Research Institute |
---|---|
Information provided by: | Renal Research Institute |
ClinicalTrials.gov Identifier: | NCT00618033 |
This study aims to show that using a dextrose (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 sugar drops. Other parameters that will be compared between the two groups are blood pressure, heart rhythm, weight gain between dialysis treatments, and tiredness after the treatment.
Condition | Intervention |
---|---|
Hemodialysis ESRD |
Procedure: Hemodialysis |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Crossover Assignment |
Official Title: | Short-Term Study of Physiologic Dialysate Dextrose Concentration in Chronic Hemodialysis Patients |
Estimated 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 |
---|---|
1: Active Comparator |
Procedure: Hemodialysis
varying concentration of glucose in dialysate
|
2: Active Comparator |
Procedure: Hemodialysis
varying concentration of glucose in dialysate
|
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
Hospitalisations or antibiotics-dependent infection during the 8 weeks preceding enrollment
Central venous catheter as hemodialysis access
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
Upper Manhattan Dialysis Center | |
New York, New York, United States, 10025 |
Principal Investigator: | Nathan W. Levin, MD | Renal Research Institute |
Responsible Party: | Renal Research Institute ( Nathan Levin, MD ) |
Study ID Numbers: | 169-07 |
Study First Received: | February 4, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00618033 |
Health Authority: | United States: Institutional Review Board |
Hemodialysis ESRD |