UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042246 |
|---|---|
| Receipt number | R000048237 |
| Scientific Title | Relationship between hemodynamic management and postoperative myocardial injury in patients undergoing hip fracture surgery |
| Date of disclosure of the study information | 2020/10/30 |
| Last modified on | 2022/10/31 11:14:03 |
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Basic information
Public title
Postoperative myocardial ischemia, myocardial infarction and congestive heart failure after hip fracture surgery
Acronym
Complications after hip fracture surgery
Scientific Title
Relationship between hemodynamic management and postoperative myocardial injury in patients undergoing hip fracture surgery
Scientific Title:Acronym
Myocardial injury after hip fracture surgery
Region
| Japan |
Condition
Condition
Hip fracture surgery
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Quantitative evaluation of the effects of preoperative increase of NT^proBNP and intraoperative hypotension on the postoperative myocardial injur
Basic objectives2
Others
Basic objectives -Others
Determination of pathophysiological process
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative serum troponin T concentration
Key secondary outcomes
(1) Perioperative NT-pro BNP concentration
(2) Preoperative troponin T concentration
(3) Intraoperative mean blood pressure
(4) Intraoperative stroke volume
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing urgent internal fixation or hemiarthroplasty
Key exclusion criteria
Preoperative pacemaker use
Preoperative chronic kidney disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
153-8515
Address
2-22-36 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
ykotake@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kawamura |
Organization
Toho University Ohashi Medical Center
Division name
Institutional review board
Zip code
153-8515
Address
2-22-36 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
Homepage URL
http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
ohashi.rinri@ext.toho-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Institutional review board, Toho University Ohashi Medical Center
Address
2-22-36 Ohashi, Meguro, Tokyo, Japan
Tel
03-3468-1251
ohashi.rinri@ext.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
東邦大学医療センター大橋病院（東京都）
Toho University Ohashi Medical Center (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 31 | Day |
Other
Other related information
(1) Determination of serum NT-pro BNP and troponin T concentration before surgery, after surgery and 1st postoperative day.
(2) Continuous monitoring of blood pressure and stroke volume with non-invasive arterial waveform analysis.
(3) Multivariable logistic regression to determine the association of postoperative increase of troponin T concentration and preoperative NT-pro BNP concentration, intraoperative mean blood pressure and stroke volume.
Management information
Registered date
| 2020 | Year | 10 | Month | 27 | Day |
Last modified on
| 2022 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048237
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
