UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026753 |
|---|---|
| Receipt number | 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 10:26:11 |
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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
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
nkshimojo@md.tsukuba.ac.jp
Sponsor or person
Institute
Emergency and Critical Care Medicine, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
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
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
èšćç
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028932
| Research Plan | |
|---|---|
| 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 |
