UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048163 |
|---|---|
| Receipt number | R000054352 |
| Scientific Title | Effect of individualized blood pressure management on postoperative outcomes in hypertensive patients undergoing major surgery |
| Date of disclosure of the study information | 2022/06/25 |
| Last modified on | 2026/02/20 15:25:39 |
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Basic information
Public title
Effect of individualized blood pressure management on postoperative outcomes in hypertensive patients undergoing major surgery
Acronym
Effect of individualized blood pressure management on postoperative outcomes in hypertensive patients undergoing major surgery
Scientific Title
Effect of individualized blood pressure management on postoperative outcomes in hypertensive patients undergoing major surgery
Scientific Title:Acronym
Effect of individualized blood pressure management on postoperative outcomes in hypertensive patients undergoing major surgery
Region
| Japan |
Condition
Condition
Hypertensive patients undergoing major surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of intraoperative individualized blood pressure management to improve postoperative outcomes in hypertensive patients undergoing major surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of acute kidney injury within 7 days after surgery
Key secondary outcomes
Incidence of AKI (stage >=2) within 7 days after surgery, initiation of renal replacement therapy (RRT) (intermittent hemodialysis or continuous hemodiafiltration) within 7 days after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intraoperative individualized blood pressure management to maintain mean blood pressure within 10% of the reference value
Interventions/Control_2
Intraoperative blood pressure management to maintain mean blood pressure 65mmHg or higher.
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
Hypertensive patients undergoing major abdominal surgery
Key exclusion criteria
1. Emergency cases
2. Patients who will receive mechanical ventilation after surgery
3. Preoperative acute kidney injury (preoperative eGFR<30 ml/min/1.73m2)
4. Kidney surgery
5. Surgery requiring hypotensive management
6. Preoperative mean blood pressure less than 75mmHg
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Suehiro |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
0666452186
suehirokoichi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Suehiro |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
0666452186
Homepage URL
suehirokoichi@yahoo.co.jp
Sponsor or person
Institute
Osaka Metropolitan University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Anesthesiology, Osaka city general hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Osaka Metropolitan University Graduate School of Medicine
Address
1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan
Tel
06-6646-6125
gr-a-knky-ethics@omu.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
Osaka Metropolitan University Graduate School of Medicine and Osaka City Genaral Hospital
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
https://zenodo.org/records/18708024
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
400
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because the manuscript has not yet been published.
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 25 | Day |
Last modified on
| 2026 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054352
