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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026753
Receipt No. R000028932
Scientific Title The protocol to control unstable tachycardia with landiolol in septic patients
Date of disclosure of the study information 2017/03/29
Last modified on 2017/03/29

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Basic information
Public title The protocol to control unstable tachycardia with landiolol in septic patients
Acronym T-START(Tsukuba-septic tachycardia therapy trial)
Scientific Title The protocol to control unstable tachycardia with landiolol in septic patients
Scientific Title:Acronym T-START(Tsukuba-septic tachycardia therapy trial)
Region
Japan

Condition
Condition Sepsis
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the therapeutic effect of landiolol for acute septic patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The prevention of organ failure
Key secondary outcomes survival rate for 30 and 60 days, Duration of intensive care unit and hospital stay etc.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Landiolol hydrochloride
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria probable sepsis (probable infection with positive qSOFA)
narrow-QRS tachycardia over 100 bpm in heart rate
Key exclusion criteria cardiogenic shock
diabetic keto-acidosis or mebolic acidosis
high grade atrial-vetricular block, sick sinus syndrome
right ventricular failure with pulmonary hypertension
allergy against landiolol
severe heart failure
severe bronchial asthma
pregnant or lactating patients
patients under 100 bpm in heart rate
pheochromocytoma without any therapy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobutake Shimojo
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address 1-1-1Tennodai, Univ, of Tsukuba, Igakuiryokei
TEL 0298533210
Email nkshimojo@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobutake Shimojo
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address 1-1-1Tennodai, Univ, of Tsukuba, Igakuiryokei
TEL 0298533210
Homepage URL
Email nkshimojo@md.tsukuba.ac.jp

Sponsor
Institute Emergency and Critical Care Medicine, Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization Ministry of Education, culture, sports, sciences and technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 èŒšćŸŽçœŒ

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 29 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
2019 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 29 Day
Last modified on
2017 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028932

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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