UMIN-CTR Clinical Trial

Basic information
Public title	Does intradialytic blood pressure drop occur more frequently during the same day after arterial catheterization? A sigle-center, retrospective cohort study.
Acronym	Does intradialytic blood pressure drop occur more frequently during the same day after arterial catheterization?
Scientific Title	Does intradialytic blood pressure drop occur more frequently during the same day after arterial catheterization? A sigle-center, retrospective cohort study.
Scientific Title:Acronym	Does intradialytic blood pressure drop occur more frequently during the same day after arterial catheterization?
Region	Japan

Condition
Condition	End stage renal failure
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess whether intradialytic blood pressure drop will occur during the same day after arterial catheter comparing with the next day.
Basic objectives2	Others
Basic objectives -Others	Factor affecting outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Systolic blood pressure less than 90mmHg during dialysis
Key secondary outcomes	Ultrafiltration volume Proportion of dialysis Interruption Serum potassium level

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who were hospitalized for the purpose of undergoing arterial catheterization in the department of cardiology, Hyogo Prefectural Amagasaki Hospital, Japan, from 1st April 2011 to 31st March 2014. Patients who underwent dialysis during the same day or the next day after arterial catheterization.
Key exclusion criteria	Patients who were admitted to the hospital for an emergency. Patients who underwent catheterization during the same day after dialysis. Patients who underwent additional dialysis with routine schedule before catheterization. Patients who received blood transfusion during dialysis. Patients who underwent continuous renal replacement therapy.
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasushi Tsujimoto
Organization	Hyogo Prefectural Amagasaki Hospital
Division name	Department Of Nephrology
Zip code
Address	1-1-1 Higashidaimotsucho, Amagasaki, Hyogo
TEL	06-6482-1521
Email	yssh0108@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Yasushi Tsujimoto
Organization	Hyogo Prefectural Amagasaki Hospital
Division name	Department Of Nephrology
Zip code
Address	1-1-1 Higashidaimotsucho, Amagasaki, Hyogo
TEL	06-6482-1521
Homepage URL
Email	yssh0108@yahoo.co.jp

Sponsor
Institute	Hyogo Prefectural Amagasaki Hospital
Institute
Department

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
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	兵庫県立尼崎病院(兵庫県)

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 11 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	Terminated
Date of protocol fixation	2015 Year 02 Month 05 Day
Date of IRB	2015 Year 01 Month 23 Day
Anticipated trial start date	2015 Year 03 Month 11 Day
Last follow-up date	2015 Year 03 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a retrospective cohort study for examining a correlation between a factor and an outcome.

Management information
Registered date	2015 Year 03 Month 11 Day
Last modified on	2019 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019461