UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of BNP and NT-pro BNP as preoperative examination in elderly patients with hip fracture
Acronym	The efficacy of BNP and NT-pro BNP as preoperative examination in elderly patients with hip fracture
Scientific Title	The efficacy of BNP and NT-pro BNP as preoperative examination in elderly patients with hip fracture
Scientific Title:Acronym	The efficacy of BNP and NT-pro BNP as preoperative examination in elderly patients with hip fracture
Region	Japan

Condition
Condition	hip fracture
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether preoperative BNP and echocardiography can predict postoperative complications in elderly patients aged >80 years old.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Death, myocardial infarction, fetal arrhythmia, congestive heart failure, and cardiac arrest within 90 days after operation.
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
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Interventions/Control_8
Interventions/Control_9
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Eligibility
Age-lower limit	80 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patient aged >80 years old undergo hip fracture operation
Key exclusion criteria	The patient who has other serious complications (new myocardial infarction, fatal arrhythmia, severe heart failure) before operation
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Sari Middle name Last name Shimizu
Organization	The department of anesthesiology and resuscitology, Shinshu University school of medicine
Division name	intensice care unit
Zip code	390-8621
Address	Asahi 3-1-1 Matsumoto Nagano
TEL	0263-37-2670
Email	sari@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Sari Middle name Last name Shimizu
Organization	Shinshu University school of medicine
Division name	The department of anesthesiology and resuscitology
Zip code	390-8621
Address	Asahi 3-1-1 Matsumoto Nagano
TEL	0263-37-2670
Homepage URL
Email	sari@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University school of medicine
Institute
Department

Funding Source
Organization	Self funding
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	Shinshu University School of Medicine Ethics Committee
Address	Asahi 3-1-1 Matsumoto Nagano
Tel	0263-37-2572
Email	mdrinri@shinshu-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 01 Month 14 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	133
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	2021 Year 01 Month 14 Day
Date of IRB	2020 Year 01 Month 09 Day
Anticipated trial start date	2021 Year 01 Month 14 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective observational study

Management information
Registered date	2021 Year 01 Month 14 Day
Last modified on	2021 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049025

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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