UMIN-CTR Clinical Trial

Basic information
Public title	Features and Outcome of Patients with preoperative Severe Hypertension
Acronym	Outcome of Hypertension
Scientific Title	Features and Outcome of Patients with preoperative Severe Hypertension
Scientific Title:Acronym	Outcome of Hypertension
Region	Japan

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

Objectives
Narrative objectives1	Abnormal hypertension is at high risk of stroke and myocardial ischemia and intervention is often necessary before the surgery. Even through careful intervention is performed before elective surgeries, you may encounter abnormally high blood pressure on admission. In this study, we want to investigate the features and outcome of patients who have been postpone or continued due to abnormal hypertension for past 5 years and examine future patients education and safety at the perioperative period.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	perioperative outcome
Key secondary outcomes	postoperative outcome during 1year

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	elective surgery patients with severe hypertansion
Key exclusion criteria	emergency surgery
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Maiko Middle name Last name Satomoto
Organization	Toho University
Division name	Anesthesiology
Zip code	1438541
Address	Ota-ku
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	1438541
Address	Ota-ku
TEL	0337624151
Homepage URL
Email	maiko.satomoto@med.toho-u.ac.jp

Sponsor
Institute	Toho University
Institute
Department

Funding Source
Organization	Course research expenses
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
Address	6-11-1 Omorinishi
Tel	0337624151
Email	maiko.satomoto@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	2019 Year 02 Month 10 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	Completed
Date of protocol fixation	2019 Year 01 Month 01 Day
Date of IRB	2018 Year 02 Month 01 Day
Anticipated trial start date	2019 Year 02 Month 10 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information	Retrospective observation study

Management information
Registered date	2019 Year 02 Month 08 Day
Last modified on	2020 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040803