UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059287 |
|---|---|
| Receipt number | R000067808 |
| Scientific Title | Evaluation of Agreement Between Shunt and Non-shunt Limb SpO2 Measurements During Hemodialysis |
| Date of disclosure of the study information | 2025/10/04 |
| Last modified on | 2025/10/04 10:24:41 |
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Basic information
Public title
Evaluation of Agreement Between Shunt and Non-shunt Limb SpO2 Measurements During Hemodialysis
Acronym
Evaluation of Agreement Between Shunt and Non-shunt Limb SpO2 Measurements During Hemodialysis
Scientific Title
Evaluation of Agreement Between Shunt and Non-shunt Limb SpO2 Measurements During Hemodialysis
Scientific Title:Acronym
Evaluation of Agreement Between Shunt and Non-shunt Limb SpO2 Measurements During Hemodialysis
Region
| Japan |
Condition
Condition
Chronic Kidney Disease(CKD),maintenance dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
During hemodialysis, both SpO2 and non-invasive blood pressure (NIBP) are measured on the non-shunt limb. However, during NIBP measurement, the SpO2 signal diminishes or is interrupted, compromising the reliability and continuity of SpO2 monitoring. Decreased SpO2 during hemodialysis can serve as an important early indicator suggesting hypotension, dehydration, or cardiovascular events associated with reduced circulating blood volume due to fluid removal, rapid changes in electrolyte and osmolarity, or the influence of dialysate temperature. However, the reduction or interruption of the SpO2 signal can delay the detection of such pathological changes, potentially increasing the risk of delayed intervention and worsening outcomes.
Therefore, this study aims to evaluate the consistency of SpO2 measurements between the shunt limb and the non-shunt limb to verify the feasibility of using the shunt limb as an alternative site for SpO2 monitoring during hemodialysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SpO2 before hemodialysis initiation, 1 hour, 2 hours, 3 hours, and after blood return
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic kidney disease patients receiving maintenance hemodialysis at the trial site
Key exclusion criteria
1)Patients suspected of having peripheral ischemia
2)Patients for whom obtaining consent for the study is difficult
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazue |
| Middle name | |
| Last name | Kojima |
Organization
Chubu University
Division name
Department of Clinical Engineering, College of Life and Health Sciences
Zip code
487-8501
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi, Japan
TEL
0568-51-1111
kkojima@fsc.chubu.ac.jp
Public contact
Name of contact person
| 1st name | Kazue |
| Middle name | |
| Last name | Kojima |
Organization
Chubu University
Division name
Department of Clinical Engineering, College of Life and Health Sciences
Zip code
487-8501
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi, Japan
TEL
0568-51-1111
Homepage URL
kkojima@fsc.chubu.ac.jp
Sponsor or person
Institute
Chubu University
Institute
Department
Personal name
Funding Source
Organization
Chubu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chubu University
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi, Japan
Tel
0568-51-1111
kkojima@fsc.chubu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20200084
Org. issuing International ID_1
Nagoya Eiseikai Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
名古屋掖済会病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 04 | 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
45
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2025 | Year | 10 | Month | 04 | Day |
Last modified on
| 2025 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067808
