UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056928 |
|---|---|
| Receipt number | R000065055 |
| Scientific Title | A prospective observational study on the effects of arteriovenous fistula on cardiac output and cardiac function |
| Date of disclosure of the study information | 2025/02/05 |
| Last modified on | 2025/02/04 11:56:39 |
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Basic information
Public title
A prospective observational study on the effects of arteriovenous fistula on cardiac output and cardiac function
Acronym
A prospective observational study on the effects of arteriovenous fistula on cardiac output and cardiac function
Scientific Title
A prospective observational study on the effects of arteriovenous fistula on cardiac output and cardiac function
Scientific Title:Acronym
A prospective observational study on the effects of arteriovenous fistula on cardiac output and cardiac function
Region
| Japan |
Condition
Condition
End-stage renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to use a non-invasive cardiac output meter to continuously and non-invasively measure changes in cardiac output before and after arteriovenous fistula creation, and to visualize the effects on cardiac function.
Basic objectives2
Others
Basic objectives -Others
Prospective Observational Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in cardiac output before and after arteriovenous fistula creation
Key secondary outcomes
Ultrasound findings of arteriovenous fistula vessels and echocardiographic findings before and after arteriovenous fistula creation
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
| 135 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing maintenance hemodialysis who undergo vascular access-related surgery at the Department of Nephrology and Hypertension, Juntendo University Hospital, between April 1, 2025 and March 31, 2027
Key exclusion criteria
Patients with sensitive skin who have difficulty attaching electrodes
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Junichiro |
| Middle name | |
| Last name | Nakata |
Organization
Juntendo University Faculity of Medicine
Division name
Department of Nephrology
Zip code
1138431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
jnakata@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | Nakata |
Organization
Juntendo University Faculity of Medicine
Division name
Department of Nephrology
Zip code
1138431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
jnakata@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculity of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo,Bunkyo-ku,Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2025 | Year | 02 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enrolling by invitation
Management information
Registered date
| 2025 | Year | 02 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065055
