NCT00618033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

June 9, 2011

Status Verified

June 1, 2011

Enrollment Period

6 months

First QC Date

February 4, 2008

Last Update Submit

June 8, 2011

Conditions

HemodialysisESRD

Keywords

HemodialysisESRD

Outcome Measures

Primary Outcomes (1)

  • Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment

    6 weeks

Secondary Outcomes (1)

  • Intradialytic blood pressure, interdialytic weight gain, serum potassium and phosphorus concentrations, arrhythmias during dialysis and in the early postdialytic period, postdialytic fatigue

    6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR
Procedure: Hemodialysis

2

ACTIVE COMPARATOR
Procedure: Hemodialysis

Interventions

HemodialysisPROCEDURE

varying concentration of glucose in dialysate

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Irving Place Dialysis Center

New York, New York, 10003, United States

Location

Yorkville Dialysis Center

New York, New York, 10128, United States

Location

Related Publications (4)

  • 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.

    PMID: 20805263RESULT

  • 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.

    PMID: 21613795RESULT

  • Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

    PMID: 37651553DERIVED

  • 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.

    PMID: 21940484DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsSorption Detoxification

Study Officials

  • Nathan W. Levin, MD

    Renal Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 18, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

June 9, 2011

Record last verified: 2011-06

Locations

US(2)