UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness of preoperative Metabolic equivalents for Geriatric patients performed Spinal Anesthesia
Acronym	Usefulness of preoperative Metabolic equivalents for Geriatric patients performed Spinal Anesthesia
Scientific Title	Usefulness of preoperative Metabolic equivalents for Geriatric patients performed Spinal Anesthesia
Scientific Title:Acronym	Usefulness of preoperative Metabolic equivalents for Geriatric patients performed Spinal Anesthesia
Region	Japan

Condition
Condition	trochanteric fracture
Classification by specialty	Orthopedics Anesthesiology Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate whether Metabolic equivalents is useful as preoperative evaluation for geriatric patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Duration of intraoperative hypotension Myocardial markers
Key secondary outcomes	Total dose of vasopressors Hepatic markers Renal markers 30 and 90 days mortality

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
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Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	the patients with trochanteric fracture who are performed spinal anesthesia
Key exclusion criteria	who cannot be performed spinal anesthesia who cannot be evaluated by Metabolic equivalents because of dementia, respiratory dysfunction, lumbar diseases and joint diseases and so on operative duration is longer than 2 hours operative breeding is more than 1000ml
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Wataru Sakai
Organization	Takikawa General City Hospital
Division name	Anesthesiology
Zip code
Address	34gou, 2ban, 2chome, Omachi, Takikawa City, Hokkaido, Japan
TEL	0125-22-4311
Email	sakaiwataru1128@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Wataru Sakai
Organization	Takikawa General City Hospital
Division name	Anesthesiology
Zip code
Address	34gou, 2ban, 2chome, Omachi, Takikawa City, Hokkaido, Japan
TEL	0125-22-4311
Homepage URL
Email	sakaiwataru1128@gmail.com

Sponsor
Institute	Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Takikawa General City Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
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IRB Contact (For public release)
Organization
Address
Tel
Email

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	2016 Year 04 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
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Date of IRB	2015 Year 03 Month 10 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2017 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	this study is started at 1/4/2016. the patients with trochanteric fracture who are performed spinal anesthesia

Management information
Registered date	2016 Year 03 Month 13 Day
Last modified on	2020 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024736