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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024429
Receipt No. 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

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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
Email 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
Email clinical_research@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Department of Cardio-Renal Medicine and Hypertension
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028117

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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