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
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
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
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
