UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041553 |
|---|---|
| Receipt number | R000047442 |
| Scientific Title | Association of postoperative troponin I levels with postoperative complications among patients undergoing noncardiac surgery: single center, prospective cohort observational study |
| Date of disclosure of the study information | 2020/08/26 |
| Last modified on | 2023/03/13 08:21:49 |
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Basic information
Public title
Association of postoperative troponin I levels with postoperative complications among patients undergoing noncardiac surgery: single center, prospective cohort observational study
Acronym
Association of postoperative troponin levels with postoperative complications
Scientific Title
Association of postoperative troponin I levels with postoperative complications among patients undergoing noncardiac surgery: single center, prospective cohort observational study
Scientific Title:Acronym
Association of postoperative troponin levels with postoperative complications
Region
| Japan |
Condition
Condition
Patients who underwent inpatients noncardiac surgery and had postoperative care in general ICU
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Oto-rhino-laryngology |
| Orthopedics | Urology | Oral surgery |
| Neurosurgery | Plastic surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine association between postoperative troponin levels and postoperative complications among the patients undergoing noncardiac
surgery
Basic objectives2
Others
Basic objectives -Others
Incidence of myocardial injury after noncardiac surgery (MINS).
To examine associations between postoperative troponin levels and hospital stay, other complications.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine there are Troponin I thresholds associated with risk of death (30-day mortality)
Key secondary outcomes
Incidence of myocardial injury after noncardiac surgery (MINS).
Association between MINS and hospital stay.
Other postoperative complications. White blood cell count, troponin I, BNP, inflammatory marker and other test results
Hemodynamic status (heart rate, blood pressure and so on)
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing noncardiac surgery and had postoperative care in our general ICU
2) Patients aged over 18.
Key exclusion criteria
) Patients who undergo cardiac surgery
2) Outpatients who require emergency surgery
3) Patients who were judged to be inappropriate as subjects by the study investigators
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Yoshihito |
| Middle name | |
| Last name | Fujita |
Organization
Aichi Medical University
Division name
anesthesiology and general intensive care unit
Zip code
480-1195
Address
1-1 Karimata Yazako Nagakute-city Aichi-prefecture Japan
TEL
0561-62-3311
fujita.yoshihito.823@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihito |
| Middle name | |
| Last name | Fujita |
Organization
Aichi Medical University
Division name
Anesthesiology and general intensive care unit
Zip code
480- 1195
Address
1-1 Karimata Yazako Nagakute-city Aichi-prefucture Japan
TEL
0561613311
Homepage URL
fujita.yoshihito.823@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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
Aichi Medical University IRB
Address
1- 1 Karimata Yazako Nagakute Aichi Japan
Tel
0561-62-3311
aichi-med@esct.bvits.com
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
| 2020 | Year | 08 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
single center, prospective cohort observational study
Management information
Registered date
| 2020 | Year | 08 | Month | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047442
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
