UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035815 |
|---|---|
| Receipt number | R000040803 |
| Scientific Title | Features and Outcome of Patients with preoperative Severe Hypertension |
| Date of disclosure of the study information | 2019/02/10 |
| Last modified on | 2020/07/10 12:30:07 |
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Basic information
Public title
Features and Outcome of Patients with preoperative Severe Hypertension
Acronym
Outcome of Hypertension
Scientific Title
Features and Outcome of Patients with preoperative Severe Hypertension
Scientific Title:Acronym
Outcome of Hypertension
Region
| Japan |
Condition
Condition
abnormal hypertension before elective surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Abnormal hypertension is at high risk of stroke and myocardial ischemia and intervention is often necessary before the surgery. Even through careful intervention is performed before elective surgeries, you may encounter abnormally high blood pressure on admission. In this study, we want to investigate the features and outcome of patients who have been postpone or continued due to abnormal hypertension for past 5 years and examine future patients education and safety at the perioperative period.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
perioperative outcome
Key secondary outcomes
postoperative outcome during 1year
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
elective surgery patients with severe hypertansion
Key exclusion criteria
emergency surgery
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Satomoto |
Organization
Toho University
Division name
Anesthesiology
Zip code
1438541
Address
Ota-ku
TEL
03-3762-4151
maiko.satomoto@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Satomoto |
Organization
Toho University
Division name
Anesthesiology
Zip code
1438541
Address
Ota-ku
TEL
0337624151
Homepage URL
maiko.satomoto@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Course research expenses
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University
Address
6-11-1 Omorinishi
Tel
0337624151
maiko.satomoto@med.toho-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 10 | 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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Retrospective observation study
Management information
Registered date
| 2019 | Year | 02 | Month | 08 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040803
