UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045306 |
|---|---|
| Receipt number | R000051281 |
| Scientific Title | Relationship between renal rSO2 and urinary NGAL concentration in cardiac surgery |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2021/08/30 14:56:35 |
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Basic information
Public title
Relationship between renal regional saturation mesured by Near-infrared spectroscopy(renal rSO2) and urinary NGAL concentration in cardiac surgery
Acronym
Relationship between renal rSO2 and urinary NGAL concentration in cardiac surgery
Scientific Title
Relationship between renal rSO2 and urinary NGAL concentration in cardiac surgery
Scientific Title:Acronym
Relationship between renal rSO2 and urinary NGAL concentration in cardiac surgery
Region
| Japan |
Condition
Condition
Acute kidney injury
Classification by specialty
| Nephrology | Anesthesiology | Cardiovascular surgery |
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between renal rSO2 during anesthesia measured by NIRS and urinary NGAL concentration in cardiac surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative tubular injury evaluated by the urinary NGAL concentration on the first day after surgery.
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
elective cardiac surgery with cardiopulmonary bypass
age>=65
preoperative eGFR>=60
the distance from the body surface to the kidneys<=4 cm
Key exclusion criteria
Consent cannnot be obtained
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Morozumi |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
153-8515
Address
2-22-36, Ohashi, Meguro, Tokyo
TEL
03-3468-1251
kohei.morozumi@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Morozumi |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
153-8515
Address
2-22-36, Ohashi, Meguro, Tokyo
TEL
03-3468-1251
Homepage URL
kohei.morozumi@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Ohashi Medical Center
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
Toho University Ohashi Medical Center
Address
2-22-36, Ohashi, Meguro, Tokyo
Tel
03-3468-1251
kohei.morozumi@med.toho-u.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
| 2021 | Year | 09 | Month | 01 | 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
| 2021 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The relationship between renal rSO2 during anesthesia measured by NIRS and the occurrence of postoperative renal injury measured by urinary NGAL concentration will be investigated.
Management information
Registered date
| 2021 | Year | 08 | Month | 30 | Day |
Last modified on
| 2021 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051281
