UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057765 |
|---|---|
| Receipt number | R000066017 |
| Scientific Title | Impact of Individualized Blood Pressure Management on Acute Kidney Injury After Thoracic Surgery: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/05/03 |
| Last modified on | 2025/05/03 11:05:04 |
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Basic information
Public title
Impact of Individualized Blood Pressure Management on Acute Kidney Injury After Thoracic Surgery: A Randomized Controlled Trial
Acronym
Impact of Individualized Blood Pressure Management on Acute Kidney Injury After Thoracic Surgery: A Randomized Controlled Trial
Scientific Title
Impact of Individualized Blood Pressure Management on Acute Kidney Injury After Thoracic Surgery: A Randomized Controlled Trial
Scientific Title:Acronym
Impact of Individualized Blood Pressure Management on Acute Kidney Injury After Thoracic Surgery: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Patients undergoing thoracic surgery
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of individualized intraoperative blood pressure management in improving postoperative outcomes in patients undergoing thoracic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative acute kidney injury
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Individualized blood pressure management targeting within 15% of preoperative baseline mean arterial pressure.
Interventions/Control_2
Standard blood pressure management targeting a mean arterial pressure > 60 mmHg intraoperatively.
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
1.Patients undergoing thoracic surgery requiring one-lung ventilation under general anesthesia.
2.Patients undergoing invasive arterial blood pressure monitoring.
Key exclusion criteria
1.Patients undergoing emergency surgery.
2.Patients whose baseline mean arterial pressure is below 70 mmHg.
3.Patients with impaired renal function (preoperative estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2).
4.Patients requiring controlled hypotension, such as those with concomitant aortic aneurysm.
5.Patients judged inappropriate by the attending anesthesiologist for any other reason.
6.Patients judged inappropriate by the attending thoracic surgeon for any other reason.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Juri |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abenoku, Osaka City, Osaka, Japan
TEL
0666452186
takataka0061@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Juri |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abenoku, Osaka City, Osaka, Japan
TEL
0666452186
Homepage URL
takataka0061@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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University Graduate School of Medicine Ethics committee
Address
1-5-7,Asahimachi, Abenoku, Osaka City, Osaka, Japan
Tel
0666456125
ethics@med.osaka-cu.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 | 05 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 03 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 03 | Day |
Last modified on
| 2025 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066017
