UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057598 |
|---|---|
| Receipt number | R000065804 |
| Scientific Title | Association between antihypertensive therapy and outcome in major surgeries: A retrospective cohort study using the DPC (Diagnosis Procedure Combination) database |
| Date of disclosure of the study information | 2025/04/14 |
| Last modified on | 2025/04/12 10:38:50 |
* 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
Association between antihypertensive therapy and outcome in major surgeries: A retrospective cohort study
Acronym
HYPER-SURG (Hypertension and Surgery Outcomes)
Scientific Title
Association between antihypertensive therapy and outcome in major surgeries: A retrospective cohort study using the DPC (Diagnosis Procedure Combination) database
Scientific Title:Acronym
HYPER-SURG (Hypertension and Surgery Outcomes)
Region
| Japan |
Condition
Condition
Adult patients undergoing major surgeries
Classification by specialty
| Medicine in general | Geriatrics | Surgery in general |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between the administration or non-administration of antihypertensive, heart failure, and kidney disease medications, as well as their combinations, and postoperative in-hospital outcomes in patients undergoing major surgeries.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between the perioperative continuation or discontinuation of antihypertensive, heart failure, and kidney disease medications and postoperative in-hospital outcomes in patients undergoing major surgeries.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital overall death
Key secondary outcomes
Functional decline in Barthel index scores during hospitalization
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 50 years or older, with a hospital stay of more than 24 hours, who underwent major surgeries between April 2014 and March 2020, were selected from the Japanese DPC database.
Key exclusion criteria
We excluded cases of second or subsequent hospital admissions during the study period, cases with missing information on BMI, ADL, or admission type (e.g., emergency admission), and cases involving multiple types of surgeries.
Target sample size
5000000
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Mandai |
Organization
Graduate School of Medical and Dental Sciences, Institute of Science Tokyo
Division name
Department of Nephrology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo, Tokyo
TEL
0338136111
smandai.kid@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Mandai |
Organization
Graduate School of Medical and Dental Sciences, Institute of Science Tokyo
Division name
Department of Nephrology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo, Tokyo
TEL
0338136111
Homepage URL
smandai.kid@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo, Tokyo
Tel
0338136111
smandai.kid@tmd.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
| 2025 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5067764
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
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective cohort study utilizing the DPC database registered between April 2014 and March 2020. It targets cases that underwent major surgeries and compares perioperative outcomes between users and non-users of antihypertensive medications, as well as by different combinations of medication use, while examining differences based on the type of surgery.
Management information
Registered date
| 2025 | Year | 04 | Month | 12 | Day |
Last modified on
| 2025 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065804
