UMIN-CTR Clinical Trial

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

Hemodialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Western University Health Sciences Research Ethics Board.

Institute

Department

Personal name

Organization

Program of Experimental Medicine, Western University.

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Canada

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

University Hospital (London), Victoria Hospital (London)

Date of disclosure of the study information

2017

Year

02

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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