UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048109 |
|---|---|
| Receipt number | R000054829 |
| Scientific Title | Perioperative risks of uncontrolled hypertension: A retrospective observational study |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2024/12/23 09:52:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Perioperative risks of uncontrolled hypertension: A retrospective observational study
Acronym
Perioperative risks of uncontrolled hypertension: A retrospective observational study
Scientific Title
Perioperative risks of uncontrolled hypertension: A retrospective observational study
Scientific Title:Acronym
Perioperative risks of uncontrolled hypertension: A retrospective observational study
Region
| Japan |
Condition
Condition
Surgical patients
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to investigate the perioperative risks of patients with uncontrolled hypertension.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative mortality
Key secondary outcomes
Incidence of postoperative cardiovascular events
Length of postoperative hospital stay
Medical costs
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
Patients who underwent surgery under general anesthesia between January 1, 2016 and December 31, 2021
Key exclusion criteria
Cardiovascular surgery, neurosurgery, and obstetric surgery.
missing data cases.
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | Taeko |
| Middle name | |
| Last name | Fukuda |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3092
taekof@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Taeko |
| Middle name | |
| Last name | Fukuda |
Organization
University of Tsukuba Hospital
Division name
Tsuchiura Clinical Education and Training Center
Zip code
305-8585
Address
2-7-14 Shimotakatu, Tsuchiura, Ibaraki
TEL
029-822-5050
Homepage URL
taekof@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization Headquarters
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Medicine, University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
Tel
029-853-3022
sien.ningenss@un.tsukuba.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
| 2022 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
2022/07/20
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
272594
Results
Hypertensive patients were at risk, even those whose BP had normalized before surgery.
Results date posted
| 2024 | Year | 12 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study was conducted using data from 68 hospitals, accessed through the Diagnosis Procedure Combination (DPC) administrative claims database, spanning from January 1, 2016, to December 31, 2021.
Participant flow
Adult patients (either sex, more than 19 years old) who underwent surgery under general anesthesia during the study period were included, whereas those undergoing neurosurgery, cardiac or large vascular surgery, obstetric surgery, and same-day surgery were excluded.
Adverse events
none
Outcome measures
mortality, ischemic heart disease, cerebrovascular disease, aortic dissection, renal failure
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Effects of age, obesity, and other comorbidities will be investigated on postoperative mortality and cardiovascular events.
Management information
Registered date
| 2022 | Year | 06 | Month | 20 | Day |
Last modified on
| 2024 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054829
