Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients (Dextrose)
Short-Term Study of Physiologic Dialysate Glucose Concentration in Chronic Hemodialysis Patients
Studieoversigt
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10128
- Yorkville Dialysis Center
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New York, New York, Forenede Stater, 10003
- Irving Place Dialysis Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 2
|
varying concentration of glucose in dialysate
|
|
Aktiv komparator: 1
|
varying concentration of glucose in dialysate
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment
Tidsramme: 6 weeks
|
6 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Intradialytic blood pressure, interdialytic weight gain, serum potassium and phosphorus concentrations, arrhythmias during dialysis and in the early postdialytic period, postdialytic fatigue
Tidsramme: 6 weeks
|
6 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Nathan W. Levin, MD, Renal Research Institute
Publikationer og nyttige links
Generelle publikationer
- Raimann JG, Kruse A, Thijssen S, Kuntsevich V, Diaz-Buxo JA, Levin NW, Kotanko P. Fatigue in hemodialysis patients with and without diabetes: results from a randomized controlled trial of two glucose-containing dialysates. Diabetes Care. 2010 Sep;33(9):e121. doi: 10.2337/dc10-1043. No abstract available.
- Ferrario M, Raimann JG, Thijssen S, Signorini MG, Kruse A, Diaz-Buxo JA, Cerutti S, Levin NW, Kotanko P. Effects of dialysate glucose concentration on heart rate variability in chronic hemodialysis patients: results of a prospective randomized trial. Kidney Blood Press Res. 2011;34(5):334-43. doi: 10.1159/000327851. Epub 2011 May 25.
- Raimann JG, Kruse A, Thijssen S, Kuntsevich V, Dabel P, Bachar M, Diaz-Buxo JA, Levin NW, Kotanko P. Metabolic effects of dialyzate glucose in chronic hemodialysis: results from a prospective, randomized crossover trial. Nephrol Dial Transplant. 2012 Apr;27(4):1559-68. doi: 10.1093/ndt/gfr520. Epub 2011 Sep 22.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 169-07
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