UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054900 |
|---|---|
| Receipt number | R000062721 |
| Scientific Title | Central arterial waveform and blood pressure change during hemodialysis |
| Date of disclosure of the study information | 2024/07/08 |
| Last modified on | 2025/07/09 12:15:59 |
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Basic information
Public title
Central arterial waveform and blood pressure change during hemodialysis
Acronym
Central arterial waveform and blood pressure change during hemodialysis
Scientific Title
Central arterial waveform and blood pressure change during hemodialysis
Scientific Title:Acronym
Central arterial waveform and blood pressure change during hemodialysis
Region
| Japan |
Condition
Condition
chronic kidney disease patients requiring regular hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of whether assessment of the arterial waveform has clinical implications for the management of regular hemodialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure levels
Key secondary outcomes
Prognosis
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Chronic kidney patients aged >18 years and received thrice-weekly maintenance hemodialysis
Key exclusion criteria
(i) nonsinus rhythm
(ii) old nonfunctional fistula on the contralateral arm from that currently used for dialysis access
(iii) Stage III.IV congestive heart failure, according to New York Heart Association classification
(iv) life expectancy of less than one year
(v) apparent infection
(vi) myocardial infarction and/or stroke within 30 days
(vii) current pregnancy
(viii) malignancy
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Ishimitsu |
Organization
Utsunomiya Central Hospital
Division name
Department of Internal Medicine
Zip code
321-0953
Address
2-1-1, Higashi-shukugou, Utsunomiya city, Tochigi, Japan
TEL
0286351110
t-ishimitsu@sun.ucatv.ne.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Iwashima |
Organization
Kansai Medical University Kori Hospital
Division name
Department of Internal Medicine
Zip code
572-8551
Address
8-45 Kori Hon-douri chou, Neyagawa city, Osaka, Japan
TEL
0728325321
Homepage URL
iwashima@geriat.med.osaka-u.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None.
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
Gotebnyama Hospital
Address
1682-2, Shin-imamiya-chou, Kanuma city, Tochigi, Japan
Tel
0289642131
touseki@gotenyama.or.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
| 2024 | Year | 07 | Month | 08 | 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
400
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
| 2020 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recording of dialysis treatment and measurements of hemodynamic parameters were performed on two consecutive dialysis days by using commercially available software (SphygmoCor XCEL; AtCor Medical, Sydney, Australia). Measurements were performed immediately before the start of hemodialysis after five minutes in the supine position, every 30 minutes during dialysis, and just before detachment of the dialysis circuit from the patient.
Management information
Registered date
| 2024 | Year | 07 | Month | 06 | Day |
Last modified on
| 2025 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062721
