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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026102
Receipt No. 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

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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
Email 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
Email thomsonb@kgh.kari.net

Sponsor
Institute Western University Health Sciences Research Ethics Board.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029994

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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