UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Pulse Wave Transit Time for detecting Postoperative Acute Kidney Injury
Acronym	Evaluation of Pulse Wave Transit Time for detecting Postoperative Acute Kidney Injury
Scientific Title	Evaluation of Pulse Wave Transit Time for detecting Postoperative Acute Kidney Injury
Scientific Title:Acronym	Evaluation of Pulse Wave Transit Time for detecting Postoperative Acute Kidney Injury
Region	Japan

Condition
Condition	Elective Spine Surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evulation of Pulse Wave Transit Time for detecting Postoperative Acute Kidney Injury
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative Acute Kidney Injury
Key secondary outcomes	Age, Gender, Height, Weight, Cardiovasucular Disease, Cerebrovascular Disease

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	105 years-old >
Gender	Male and Female
Key inclusion criteria	Elective Spine Surgery Patients
Key exclusion criteria	Hemodialysis, Aortic Artery Replacement
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Yamashita
Organization	Japanese Red Cross Society Kochi Hospital
Division name	Division of Critical Care
Zip code	7808562
Address	1-4-63-11 Hadaminamimachi, Kochi-shi, Kochi
TEL	0888221201
Email	krch.yamashita2017@gmail.com

Public contact
Name of contact person	1st name Koichi Middle name Last name Yamashita
Organization	Japanese Red Cross Society Kochi Hospital
Division name	Division of Critical Care
Zip code	7808562
Address	1-4-63-11 Hadaminamimachi, Kochi-shi, Kochi
TEL	0888221201
Homepage URL
Email	krch.yamashita2017@gmail.com

Sponsor
Institute	Japanese Red Cross Society Kochi Hospital
Institute
Department

Funding Source
Organization	Japanese Red Cross Society Kochi Hospital
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	Japanese Red Cross Society Kochi Hospital
Address	1-4-63-11 Hadaminamimachi, Kochi-shi, Kochi
Tel	0888221201
Email	krch.yamashita2017@gmail.com

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	2022 Year 04 Month 25 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	74
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	No longer recruiting
Date of protocol fixation	2019 Year 12 Month 10 Day
Date of IRB	2021 Year 12 Month 10 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2021 Year 08 Month 31 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded	2022 Year 12 Month 31 Day

Other
Other related information	The data cannot be connected with a computer independent of the Internet to manage it, and to give an original layout number.

Management information
Registered date	2022 Year 04 Month 25 Day
Last modified on	2022 Year 04 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054261