UMIN-CTR Clinical Trial

Basic information
Public title	Association between uncontrolled hypertension before induction of anesthesia and postoperative AKI
Acronym	Association between uncontrolled hypertension before induction of anesthesia and postoperative AKI
Scientific Title	Association between uncontrolled hypertension before induction of anesthesia and postoperative AKI
Scientific Title:Acronym	Association between uncontrolled hypertension before induction of anesthesia and postoperative AKI
Region	Japan

Condition
Condition	abnormal hypertension before elective surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The development of postoperative acute kidney injury (AKI) is associated with worse outcomes. Therefore, it is important to identify the incidence and risk factors of postoperative AKI. Chronic hypertension has been reported as a risk factor for postoperative AKI. On the other hand, uncontrolled hypertension before the induction of anesthesia is often encountered, but there is no report showing the relationship between this hypertension and postoperative AKI. The purpose of this study is to investigate the relation between uncontrolled hypertension before the induction of anesthesia and incidence of postoperative AKI and to identify perioperative risk factors of that.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome of this study is occurrence of postoperative AKI by the KDIGO criteria.
Key secondary outcomes	Secondary outcome is preoperative and intraoperative risk factors of postoperative AKI.

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	150 years-old >
Gender	Male and Female
Key inclusion criteria	elective surgery patients with severe hypertansion
Key exclusion criteria	emergency surgery
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Maiko Middle name Last name Satomoto
Organization	Toho University
Division name	Anesthesiology
Zip code	143-8541
Address	6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL	03-3762-4151
Email	maiko.satomoto@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Maiko Middle name Last name Satomoto
Organization	Toho University
Division name	Anesthesiology
Zip code	143-8541
Address	6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL	03-3762-4151
Homepage URL
Email	maiko.satomoto@med.toho-u.ac.jp

Sponsor
Institute	Toho University School of Medicine, Department of Anesthesiology
Institute
Department

Funding Source
Organization	Toho University School of Medicine, Department of Anesthesiology
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 Ethics Review Board
Address	6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
Tel	0337624151
Email	omori.rinri@ext.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	2019 Year 12 Month 19 Day

Related information
URL releasing protocol	DOI: 10.14994/tohojmed.2020-018
Publication of results	Unpublished

Result
URL related to results and publications	DOI: 10.14994/tohojmed.2020-018
Number of participants that the trial has enrolled	274
Results	DOI: 10.14994/tohojmed.2020-018
Results date posted	2021 Year 06 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 03 Month 01 Day
Baseline Characteristics	DOI: 10.14994/tohojmed.2020-018
Participant flow	DOI: 10.14994/tohojmed.2020-018
Adverse events	DOI: 10.14994/tohojmed.2020-018
Outcome measures	DOI: 10.14994/tohojmed.2020-018
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 01 Day
Date of IRB	2018 Year 02 Month 01 Day
Anticipated trial start date	2019 Year 12 Month 20 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective observation study

Management information
Registered date	2019 Year 12 Month 19 Day
Last modified on	2021 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044398