UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026102 |
|---|---|
| Receipt number | R000029994 |
| Scientific Title | Effect of Personalized Dialysate Sodium Prescription on Plasma Sodium Concentration and Sodium Setpoint in Conventional, Quotidian and Nocturnal Hemodialysis. |
| Date of disclosure of the study information | 2017/02/12 |
| Last modified on | 2017/02/12 10:20:03 |
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Basic information
Public title
Effect of Personalized Dialysate Sodium Prescription on Plasma Sodium Concentration and Sodium Setpoint in Conventional, Quotidian and Nocturnal Hemodialysis.
Acronym
Personalized Dialysate Sodium concentration and effect on sodium setpoint and clinical outcomes in Home Hemodialysis patients.
Scientific Title
Effect of Personalized Dialysate Sodium Prescription on Plasma Sodium Concentration and Sodium Setpoint in Conventional, Quotidian and Nocturnal Hemodialysis.
Scientific Title:Acronym
Personalized Dialysate Sodium concentration and effect on sodium setpoint and clinical outcomes in Home Hemodialysis patients.
Region
| North America |
Condition
Condition
Hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To determine clinical endpoints related to personalization of dialysate sodium concentration in patients on hemodialysis of varying duration and frequency.
2. To determine change in sodium setpoint with personalization of dialysate sodium concentration in patients on hemodialysis of varying duration and frequency
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
1. Interdialytic weight gain
Key secondary outcomes
1. Pre- and post-dialysis systolic and diastolic blood pressure.
2. Change in blood pressure (systolic and diastolic) during hemodialysis
3. Change in pre-dialysis patient plasma sodium setpoint.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention 1 = Personalized dialysate sodium set to 3 mmol/L above patient plasma pre-dialysis sodium setpoint.
Interventions/Control_2
Intervention 2 = Personalized dialysate sodium set to 3 mmol/L below patient plasma pre-dialysis sodium setpoint.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients in the home hemodialysis program of the Southwestern Ontario Regional Renal Program.
Key exclusion criteria
Age under 18, pregnancy, not expected to survive 6 months.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr. Benjamin Thomson |
Organization
Queen's University
Division name
Nephrology
Zip code
Address
76 Stuart Street, Kingston ON, K7L2V7
TEL
226-678-7067
thomsonb@kgh.kari.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dr. Benjamin Thomson |
Organization
Queen's University
Division name
Nephrology
Zip code
Address
76 Stuart Street, Kingston ON Canada, K7L2V7
TEL
6135496666
Homepage URL
thomsonb@kgh.kari.net
Sponsor or person
Institute
Western University Health Sciences Research Ethics Board.
Institute
Department
Personal name
Funding Source
Organization
Program of Experimental Medicine, Western University.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Canada
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
University Hospital (London), Victoria Hospital (London)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1. Plasma Na+ decreased during hemodialysis in LOWDialSOD study period (136.8 to 135.0 mmol/L, p=0.002).
2. Pre-Na+ setpoint (137.4 to 136.8 mmol/L, p=0.03) and Pre-Na+ setpoint slope (0.014 to -0.015 mmol/L/day, p=0.009) decreased from HIGHDialSOD to LOWDialSOD study periods.
3. Interdialytic weight gain (2.15 vs 1.90 L, p=0.002), IDWG as % of target weight (IDWG%)(2.78 vs 2.39%, p=0.002), pre-dialysis systolic (143.3 vs 138.3 mm Hg, p=0.001), diastolic (78.6 vs 75.6 mm Hg, p=0.008) and mean arterial pressure (100.2 vs. 96.5 mm Hg, p=0.003), post-dialysis systolic (135.4 vs. 130.0 mm Hg, p=0.04), diastolic (75.8 vs 72.4 mm Hg, p=0.006) and mean arterial pressure (95.7 vs. 91.6 mm Hg, p=0.009) were higher in DIALHighSOD than DIALLowSOD. Hemodialysis frequency was associated with decreased (R = -0.295, slope = -0.002, p=0.034) IDWG%, while the opposite was seen with hemodialysis duration (R = 0.507, slope = 0.002, p<0.001). Hemodialysis duration increased intradialytic change in diastolic blood pressure (R=0.280, slope = 1.127, p=0.044), while hemodialysis frequency increased post-dialysis diastolic blood pressure (R=0.366, slope = 3.464, p=0.008)
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 12 | Day |
Last modified on
| 2017 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029994
