UMIN-CTR Clinical Trial

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
Registered date	File name

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