UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024429 |
|---|---|
| Receipt number | R000028117 |
| Scientific Title | Application of blood pressure variability as an early-warning system for a decline in blood pressure during the dialysis |
| Date of disclosure of the study information | 2016/10/16 |
| Last modified on | 2016/10/17 22:14:45 |
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Basic information
Public title
Application of blood pressure variability as an early-warning system for a decline in blood pressure during the dialysis
Acronym
BP variability as a predictor of BP decline during dialysis
Scientific Title
Application of blood pressure variability as an early-warning system for a decline in blood pressure during the dialysis
Scientific Title:Acronym
BP variability as a predictor of BP decline during dialysis
Region
| Japan |
Condition
Condition
Patients undergoing hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether blood pressure variabilities obtained by continuous noninvasive blood pressure monitoring precede a decline in blood pressure; development of an early-warning system for hypotension during the dialysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
relationship between BP variability obtained by continuous noninvasive blood pressure monitoring and systolic blood pressure fall 25% in 15 minutes requiring following procedures: fluid replacement, oxygen inhalation, leg raising, halting of the treatment, decrease in dialysate temperature, or slowing ultrafiltration rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
continuous noninvasive arterial blood pressure monitoring (CNAPHD)
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
1) Treated with hemodialysis therapy
at Nagoya City University Hospital and its affiliated hospital
2) age 20 years or more, regardless of gender
3) documented informed consent
Key exclusion criteria
1) ill-suited for continuous noninvasive blood pressure monitoring (CNAPHD)
2) discrepancy in measured systolic BP values between upper arm measuring and CNAPHD by 20 or more mmHg.
3) presence/possibility for pregnancy/lactation
4) any reason for ineligibility suggested by the attending doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio FUKUDA |
Organization
Nagoya City University Hospital
Division name
Division of Nephrology, Dialysis Center
Zip code
Address
1 Kawasumi, Mizuho-ku, Nasgoya 467-8601, Japan
TEL
81-52-853-8221
m-fukuda@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyoko Suzuki |
Organization
Nagoya City University Hospital
Division name
Clinical Research Management Center
Zip code
Address
1 Kawasumi, Mizuho-ku, Nasgoya 467-8602, Japan
TEL
81-52-858-7215
Homepage URL
http://www.med.nagoya-cu.ac.jp/cr.dir/index.html
clinical_research@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Department of Cardio-Renal Medicine and Hypertension
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
1) Department of Medical Education, Nagoya City University Graduate School of Medical Sciences
2) Department of Informatics and Media Design, Nagoya City University Graduate School of Design and Architecture
3) Department of Mechanical Science and Bioengineering
Osaka University
4) Nagoya City East Medical Center
5) Asahi Rousai Hospital
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
名古屋市立大学病院 (愛知県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 16 | 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
| 2016 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 16 | Day |
Last modified on
| 2016 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028117
