UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044490 |
|---|---|
| Receipt number | R000050299 |
| Scientific Title | A prospective observational study of changes in blood levels of thiamine, ascorbic acid, cortisol, and copeptin in patients with sepsis ;(Thiamine, Ascorbic acid, Cortisol, and Copeptin evaluation) study |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2022/08/17 16:46:02 |
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Basic information
Public title
A prospective observational study of changes in blood levels of thiamine, ascorbic acid, cortisol, and copeptin in patients with sepsis
Acronym
TACTIC study
Scientific Title
A prospective observational study of changes in blood levels of thiamine, ascorbic acid, cortisol, and copeptin in patients with sepsis ;(Thiamine, Ascorbic acid, Cortisol, and Copeptin evaluation) study
Scientific Title:Acronym
TACTIC study
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between changes in blood levels of vitamin B1, vitamin C, cortisol, and vasopressin (copeptin) and mortality in patients with sepsis.
Basic objectives2
Others
Basic objectives -Others
To collect background data for identifying patient groups and target blood levels for which metabolic resuscitation is effective in sepsis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
28-days mortality
Key secondary outcomes
Changes in SOFA score on the 4th day
Hospital mortality
Refractory shock (inadequate hemodynamic response to noradrenalin administration)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with sepsis by sepsis-3 at the Emergency department.
Key exclusion criteria
Patients already diagnosed with sepsis at another hospital
Patients who did not consent to this study
Patients after cardiopulmonary arrest resuscitation
Patients judged to be ineligible by attending physicians
For patients who declined aggressive treatment by the third day of hospitalization, data after the decline of treatment will not be used.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Kushimoto |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Emergency and Critical Care Medicine
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7489
kussie@emergency-medicine.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Emergency and Critical Care Medicine
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7489
Homepage URL
information@emergency-medicine.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Division of Emergency and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
Division of Emergency and Critical Care Medicine
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
東北大学病院（宮城県）、大崎市民病院（宮城県）、石巻赤十字病院（宮城県）、東北医科薬科大学病院（宮城県）、仙台市立病院（宮城県）、仙台医療センター（宮城県）、みやぎ県南中核病院（宮城県）、秋田大学病院（秋田県）、山形大学病院（山形県）、山形県立中央病院（山形県）、新潟大学医歯学総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Prospective Observational Study
Recruitment method: All patients who admitted the facility from September 2021 to March 2024 and met the selection criteria
Measurements: Blood levels of vitamin B1, vitamin C, cortisol, and copeptin at the time of admission, 24 hours, and 48 hours later
Management information
Registered date
| 2021 | Year | 06 | Month | 10 | Day |
Last modified on
| 2022 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050299
