UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057845 |
|---|---|
| Receipt number | R000065752 |
| Scientific Title | A Study on the Impact of Intraoperative Blood Pressure and Circulating Plasma Volume on Renal Perfusion |
| Date of disclosure of the study information | 2025/05/13 |
| Last modified on | 2025/05/13 00:31:51 |
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Basic information
Public title
A Study on the Impact of Intraoperative Blood Pressure and Circulating Plasma Volume on Renal Perfusion
Acronym
A Study on the Impact of Intraoperative Blood Pressure and Circulating Plasma Volume on Renal Perfusion
Scientific Title
A Study on the Impact of Intraoperative Blood Pressure and Circulating Plasma Volume on Renal Perfusion
Scientific Title:Acronym
A Study on the Impact of Intraoperative Blood Pressure and Circulating Plasma Volume on Renal Perfusion
Region
| Japan |
Condition
Condition
Patients scheduled for surgery under general anesthesia
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In an aging society where chronic hypertension is increasingly common, it is questionable whether maintaining a uniform intraoperative mean arterial pressure (MAP) of 65 mmHg is appropriate for all patients. It may be more beneficial to set individualized blood pressure targets based on each patient's baseline. Furthermore, ensuring adequate circulating plasma volume rather than focusing solely on blood pressure may be more effective in preserving organ perfusion. This study aims to investigate this hypothesis by evaluating renal perfusion as a representative indicator.
Basic objectives2
Others
Basic objectives -Others
This study investigates how renal perfusion changes during the transition from the standard target blood pressure (MAP>65 mmHg) to an individualized target based on preoperative blood pressure (defined as within 10% of the patient's baseline blood pressure measured after hospital admission). In addition, we examine how renal perfusion is affected not only by blood pressure but also by relative hypovolemia, as assessed by respiratory variation in pulse pressure. The aim is to identify the optimal range of hemodynamic parameters that best maintain renal perfusion during surgery.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Renal tissue oxygenation measured by NIRS during surgery
Key secondary outcomes
cerebral tissue oxygenation measured by NIRS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Before induction of anesthesia in the operating room, ultrasound is used to identify the location of the left and right kidneys, and NIRS sensors are then applied to the corresponding areas on the back. A NIRS sensor is also placed on the forehead (over the dominant cerebral hemisphere).During surgery, blood pressure will not be intentionally manipulated (either lowered or raised); standard anesthetic management will be maintained, and NIRS values will be continuously monitored. The fraction of inspired oxygen (FiO2) will be maintained at 60% throughout the surgery.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 65 years or older
Patients diagnosed with hypertension and receiving antihypertensive medication
Patients scheduled for elective surgery requiring both arterial catheter insertion and cardiac output monitoring
Patients scheduled for surgery in the supine position
Patients in whom preoperative CT imaging shows a distance of less than 30 mm from the skin surface of the back to the surface of either kidney
In the absence of preoperative trunk CT, patients with a body mass index (BMI) of less than 18
Key exclusion criteria
Patients with an ejection fraction <40%
Patients with atrial fibrillation
Patients with severe chronic obstructive pulmonary disease (COPD)
Patients with right heart failure
Patients undergoing surgery requiring one-lung ventilation
Patients with chronic kidney disease (eGFR <60 mL/min/1.73 m2)
Patients requiring cardiopulmonary bypass
Patients undergoing aortic surgery
Patients undergoing surgery involving the kidneys or adrenal glands
Patients with documented carotid artery stenosis
Patients in whom preoperative ultrasound on the day of surgery shows a distance of >30 mm from the skin surface to the kidney surface
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | YUSUKE |
| Middle name | |
| Last name | IIZUKA |
Organization
Saitama Medical center, jichi medical university
Division name
Department of anesthesiology and critical care medicine
Zip code
3308503
Address
1-847, amanuma town, Omiya-ku, Saitama City, Saitama, Japan
TEL
+81486472111
zukarinn@gmail.com
Public contact
Name of contact person
| 1st name | YUSUKE |
| Middle name | |
| Last name | IIZUKA |
Organization
Jichi medical university, saitama medical center
Division name
Department of anesthesiology and critical care medicine
Zip code
330-8503
Address
1-847, amanuma town, Omiya-ku, Saitama City, Saitama, Japan
TEL
+81486472111
Homepage URL
zukarinn@gmail.com
Sponsor or person
Institute
Jichi medical university
Institute
Department
Personal name
Funding Source
Organization
Scholarship Donation from Senko Medical Instrument Mfg. Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Anesthesiology and Critical care medicine, Jichi medical university, Saitama medical center
Address
1-847, amanuma town, Omiya-ku, Saitama City, Saitama, Japan
Tel
+81486472111
s-suishin@jichi.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 | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 09 | 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
Management information
Registered date
| 2025 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065752
