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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021772
Receipt No. R000023193
Scientific Title NT-proBNP as an indicator of surgical stress on the patients compromised with chronic heart failure
Date of disclosure of the study information 2016/04/04
Last modified on 2016/04/04

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Basic information
Public title NT-proBNP as an indicator of surgical stress on the patients compromised with chronic heart failure
Acronym NT-proBNP as an indicator of surgical stress on the patients compromised with chronic heart failure
Scientific Title NT-proBNP as an indicator of surgical stress on the patients compromised with chronic heart failure
Scientific Title:Acronym NT-proBNP as an indicator of surgical stress on the patients compromised with chronic heart failure
Region
Japan

Condition
Condition Patients with chronic heart failure undergoing oral surgery
Classification by specialty
Anesthesiology Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the influence of surgical stress on the patients with chronic heart failure by indicator of NT-proBNP.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in NT-proBNP before and after surgery
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
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 The enrolled patients have chronic heart failure and are 20 years or older; all the patients undergoing oral surgery.
Key exclusion criteria Patients with dementia, intellectual disability, or cerebral palsy are excluded from the study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Gomi
Organization Showa University School of Dentistry
Division name Department of Perioperative Medicine,Division of Anesthesiology
Zip code
Address 2-1-1 Kitasenzoku, Otaku, Tokyo
TEL 03-3787-1151
Email yuki-1109@dent.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Gomi
Organization Showa University School of Dentistry
Division name Department of Perioperative Medicine,Division of Anesthesiology
Zip code
Address 2-1-1 Kitasenzoku, Otaku, Tokyo
TEL 03-3787-1151
Homepage URL
Email yuki-1109@dent.showa-u.ac.jp

Sponsor
Institute Department of Perioperative Medicine,Division of Anesthesiology,Showa University School of Dentistry
Institute
Department

Funding Source
Organization None
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
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 昭和大学歯科病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2012 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Measurement item
(1) Blood test (including NT-proBNP)
(2) 12-lead electrocardiogram
(3) Simple chest X-ray
(4) Questionnaire (on the first postoperative day)


Management information
Registered date
2016 Year 04 Month 04 Day
Last modified on
2016 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023193

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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