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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016773
Receipt No. R000019461
Scientific Title Does intradialytic blood pressure drop occur more frequently during the same day after arterial catheterization? A sigle-center, retrospective cohort study.
Date of disclosure of the study information 2015/03/11
Last modified on 2019/09/13

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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

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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