UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Application of blood pressure variability as an early-warning system for a decline in blood pressure during the dialysis
Title of the study (Brief title)	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	Michio FUKUDA
Organization	Nagoya City University Hospital
Division name	Division of Nephrology, Dialysis Center
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	Miyoko Suzuki
Organization	Nagoya City University Hospital
Division name	Clinical Research Management Center
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

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 08 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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