UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062442 |
|---|---|
| Receipt number | R000071438 |
| Scientific Title | Effect of Intraoperative Amino Acid Administration on Postoperative Renal Function in Patients Undergoing Open Abdominal Aortic Aneurysm Repair: A Single-Center Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/08/03 |
| Last modified on | 2026/08/02 18:07:03 |
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Basic information
Public title
A Retrospective Observational Study of the Association Between Intraoperative Amino Acid Administration and Postoperative Renal Function in Patients Undergoing Open Abdominal Aortic Aneurysm Repair
Acronym
AAA-AA Study
Scientific Title
Effect of Intraoperative Amino Acid Administration on Postoperative Renal Function in Patients Undergoing Open Abdominal Aortic Aneurysm Repair: A Single-Center Retrospective Cohort Study
Scientific Title:Acronym
AAA-AA Study
Region
| Japan |
Condition
Condition
Abdominal Aortic Aneurysm
Classification by specialty
| Vascular surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this retrospective cohort study is to investigate the effect of intraoperative amino acid administration on postoperative renal function in patients undergoing open abdominal aortic aneurysm repair. The primary outcome is the change in renal function on postoperative day 1 (eGFR or Cr), and the secondary outcome is the incidence of postoperative acute kidney injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in serum creatinine concentration from the preoperative value to postoperative day 1 (Cr: serum creatinine on postoperative day 1 minus preoperative serum creatinine).
Key secondary outcomes
Incidence of postoperative acute kidney injury (AKI) according to the KDIGO criteria.
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
Adult patients who underwent open surgical repair for abdominal aortic aneurysm at our institution between January 2019 and December 2025.
Key exclusion criteria
1. Patients undergoing emergency surgery.
2. Patients with a preoperative serum creatinine level of 2.0 mg/dL or higher.
3. Patients receiving maintenance dialysis preoperatively.
4. Patients undergoing complex surgical procedures, such as renal artery reconstruction.
Target sample size
107
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Minamigawa |
Organization
Osaka medical and pharmaceutical university hospital
Division name
department of Anesthesiology
Zip code
5698686
Address
2-7, Daigakuchou, Takatsuki City, Osaka
TEL
0726831221
yuusuke.minamigawa@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Minamigawa |
Organization
Osaka medical and pharmaceutical university hospital
Division name
department of Anesthesiology
Zip code
5698686
Address
2-7, Daigakuchou, Takatsuki City, Osaka
TEL
0726831221
Homepage URL
yuusuke.minamigawa@ompu.ac.jp
Sponsor or person
Institute
Osaka medical and pharmaceutical university
Institute
Department
Personal name
Funding Source
Organization
Osaka medical and pharmaceutical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka medical and pharmaceutical university
Address
2-7, Daigakuchou, Takatsuki city, Osaka
Tel
0726831221
rinri@ompu.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
| 2026 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective observational study of patients undergoing open abdominal aortic aneurysm repair. Data on patient characteristics, intraoperative amino acid administration and weight-adjusted amino acid dose (g/kg), aortic cross-clamp level and duration, and perioperative renal function will be collected from medical and anesthesia records. Postoperative renal function will be compared between patients who received and did not receive intraoperative amino acid administration, and the association between weight-adjusted amino acid dose and postoperative renal function will also be evaluated.
Management information
Registered date
| 2026 | Year | 08 | Month | 02 | Day |
Last modified on
| 2026 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071438
