UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049474 |
|---|---|
| Receipt number | R000056329 |
| Scientific Title | Effects of dialysis fluid on biological responses including ECG QTc |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2022/11/10 15:44:51 |
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Basic information
Public title
Effect of dialysis fluid on ECG and other biological responses
Acronym
Dialysate QTc Study
Scientific Title
Effects of dialysis fluid on biological responses including ECG QTc
Scientific Title:Acronym
Dialysate QTc Study
Region
| Japan |
Condition
Condition
End-stage renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Currently, dialysate solutions used by dialysis patients in Japan are relatively standardized, especially electrolytes (potassium, magnesium, calcium, and bicarbonate concentrations) are similar in all dialysate solutions, and the vulnerable elderly and young patients with low dietary intake are receiving dialysis treatment using dialysate solutions with the same composition. In recent years, large clinical studies have shown that the control of these electrolytes is not so much about pre-dialysis values, but rather about pre- and post-dialysis concentration gradients, or the gradient between blood and dialysate concentrations, that strongly influence events and life outcome of dialysis patients. It has been speculated that rapid electrolyte changes during dialysis may lead to acquired QT prolongation, arrhythmia, and sudden death, but this has not yet been clarified clinically.
In this study, we will clarify how electrolyte fluctuations before and after dialysis affect the electrocardiographic changes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short-term cross-sectional study
QTc changes with dialysate
Long-term observational study
Relationship between QT/C and change in each assessment point of electrolyte indices in blood
Key secondary outcomes
Short-term cross-sectional study
Electrolyte (Mg, K, Ca) blood and dialysate concentration gradients in relation to QT/C and pulse rate
Long-term observational study
Relationship between changes in blood electrolyte indices at each endpoint and ABI, PWV, calcification index, events, and subjective symptoms
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are currently attending or hospitalized at the hospital and are scheduled to change their dialysis solution, and who have given consent for the change of dialysis solution and for this study.
Key exclusion criteria
Patients with a previously prolonged QTc of >470 ms.
Patients with atrial fibrillation.
Patients taking digitalis.
Patients who are minors.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | TAKAHIRO |
| Middle name | |
| Last name | KURAGANO |
Organization
Hyogo Medical University Hospital
Division name
Cardiovascular and renal dialysis Internal Medicine
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
TEL
0798456111
kuragano@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | YASUYUKI |
| Middle name | |
| Last name | MIMURA |
Organization
Hyogo Medical University Hospital
Division name
Cardiovascular and renal dialysis Internal Medicine
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
TEL
0798456521
Homepage URL
ya-mimura@hyo-med.ac.ip
Sponsor or person
Institute
Hyogo Medical University Hospital
Cardiovascular and renal dialysis Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo Medical University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University Hospital ethics committee
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
Tel
0798456066
rinsys@hyo-med.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Short-term cross-sectional study
Under the condition of dialysate A (Carbostar M solution: Na140mEq/L K2mEq/L Ca3mEq/L Mg1mEq/L CL110mEq/L HCO3-35mEq/L Citric acid 2mEq/L) currently in use, on 2 days of dialysis in the beginning of the week and 1 day of dialysis in the middle of the week, the following data were collected: pre-dialysis, 1 hour after dialysis started, QTc change in ECG and blood samples (electrolyte and acid-base balance including K, Ca, Mg and HCO3-) at the end of dialysis. and at the end of dialysis, and blood samples (electrolytes and acid-base equilibrium including K, Ca, Mg, and HCO3-) will be collected. Blood samples will be drawn from the site of normal puncture for dialysis, and no new puncture will be made. During hemodialysis, blood is collected from within the hemodialysis de-epithelialization circuit, so no new punctures are required. Blood samples during dialysis are collected for research purposes, and approximately 10 mL of blood is collected before, during, and after dialysis.
Next, the ECG QTc changes and electrolyte-acid-base balance changes will be measured at 2 and 4 weeks after the change to dialysate B (Kinder 5: Na140mEq/L K2.3mEq/L Ca2.6mEq/L Mg1.2mEq/L CL113.9mEq/L HCO3-30mEq/L acetic acid 4.2mEq/L) according to the same schedule. The changes in ECG QTc and electrolyte-acid-base equilibrium will be measured at 2 and 4 weeks after the changeover.
As for ECGs, they are usually performed once every 1-2 months, plus multiple times during dialysis time, which is the objective of this study.
Management information
Registered date
| 2022 | Year | 11 | Month | 10 | Day |
Last modified on
| 2022 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056329
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