UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The protocol to control unstable tachycardia with landiolol in septic patients
Title of the study (Brief title)	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	Nobutake Shimojo
Organization	University of Tsukuba
Division name	Faculty of Medicine
Address	1-1-1Tennodai, Univ, of Tsukuba, Igakuiryokei
TEL	0298533210
Email	nkshimojo@md.tsukuba.ac.jp

Public contact
Name of contact person	Nobutake Shimojo
Organization	University of Tsukuba
Division name	Faculty of Medicine
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)

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	茨城県

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 29 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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