HemodialysisDextroseNCT00618033
Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients
A study testing Hemodialysis in people with Hemodialysis and ESRD, run by Renal Research Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, ESRD
- What is being tested?
- Hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Irving Place Dialysis Center
New York, New York, 10003
Yorkville Dialysis Center
New York, New York, 10128
About this study
Official title: 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.
Read the 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
- Conditions
- Hemodialysis, ESRD
- Being tested
- Hemodialysis
- Keywords
- Hemodialysis, ESRD
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemodialysisProcedure or surgery
varying concentration of glucose in dialysate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Procedure: Hemodialysis |
| 2 | Active comparator | Not described Receives: Procedure: Hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renal Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Nathan W. Levin, MD, Principal investigator, Renal Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618033
- Sponsor's protocol ID
- 169-07
- Acronym
- Dextrose
- Status last verified
- Jun 2011
- First submitted
- 4 Feb 2008
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20805263Ferrario 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.
PubMed 21613795Natale 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.
PubMed 37651553Raimann 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.
PubMed 21940484
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Study of Physiologic Dialysate Glucose Concentration in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00618033
- Acronym / sponsor ID
- Dextrose / 169-07
- Conditions
- Hemodialysis, ESRD
- Keywords
- Hemodialysis, ESRD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Renal Research InstituteUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Hemodialysis |
| 2 | Active comparator | Procedure: Hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodialysisvarying concentration of glucose in dialysate | Procedure or surgery | 1, 2 |
Primary outcome
Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment
Time frame: 6 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
- Results publication: PubMed 20805263Raimann 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.
- Results publication: PubMed 21613795Ferrario 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.
- Derived from this study: PubMed 37651553Natale 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.
- Derived from this study: PubMed 21940484Raimann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan W. Levin, MD principal investigator
Renal Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis in people with Hemodialysis and ESRD, run by Renal Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00618033, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2011.