UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021462 |
|---|---|
| Receipt number | R000024736 |
| Scientific Title | Usefulness of preoperative Metabolic equivalents for Geriatric patients performed Spinal Anesthesia |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2020/05/27 09:52:51 |
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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
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
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
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
sakaiwataru1128@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Takikawa General City Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024736
