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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Hemodialysis | |
Classification by specialty |
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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
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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 |
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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 | ||
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Eligibility | ||||
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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 |
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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 |
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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 | |
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 | |
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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 |
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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) |
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Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029994 |
Research Plan | |
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Research case data | |
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