UMIN-CTR Clinical Trial

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
Email	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
Email	kohei.morozumi@med.toho-u.ac.jp

Sponsor
Institute	Toho University Ohashi Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051281