Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-01-01 @ 12:37 AM
Study NCT ID:
NCT00618033
Status:
COMPLETED
Last Update Posted:
2011-06-09
First Post:
2008-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients
Sponsor:
Renal Research Institute
Organization:
Study Overview
Official Title:
Short-Term Study of Physiologic Dialysate Glucose Concentration in Chronic Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Dextrose
Brief Summary:
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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: