UMIN-CTR Clinical Trial

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
Email	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
Email	information@emergency-medicine.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine Division of Emergency and Critical Care Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050299