UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015692
Receipt number R000018226
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 2014/11/20
Last modified on 2015/03/11 11:04:45

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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

Pragmatic

Developmental phase

Not applicable


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 or person

Institute

Hyogo Prefectural Amagasaki Hospital

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


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

2014 Year 11 Month 20 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

2014 Year 10 Month 16 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 20 Day

Last follow-up date


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

2014 Year 11 Month 14 Day

Last modified on

2015 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018226


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name