UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023922 |
|---|---|
| Receipt number | R000027546 |
| Scientific Title | Tricuspid annular plane systolic excursion / Left Ventricular Outflow Tract Velocity Time Integral (TAPSE / LVOT VTI) ratio to predict fluid responsiveness in critically ill patients: a pilot study |
| Date of disclosure of the study information | 2016/09/03 |
| Last modified on | 2019/09/06 12:03:10 |
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Basic information
Public title
Tricuspid annular plane systolic excursion / Left Ventricular Outflow Tract Velocity Time Integral (TAPSE / LVOT VTI) ratio to predict fluid responsiveness in critically ill patients: a pilot study
Acronym
TAPSE / LVOT VTI ratio to predict fluid responsiveness in critically ill patients
Scientific Title
Tricuspid annular plane systolic excursion / Left Ventricular Outflow Tract Velocity Time Integral (TAPSE / LVOT VTI) ratio to predict fluid responsiveness in critically ill patients: a pilot study
Scientific Title:Acronym
TAPSE / LVOT VTI ratio to predict fluid responsiveness in critically ill patients
Region
| Japan |
Condition
Condition
Hemodynamic unstability
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Pneumology | Endocrinology and Metabolism | Neurology |
| Infectious disease | Surgery in general | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the usefulness of TAPSE/LVOT VTI ratio and to find the cutoff value of TAPSE/LVOT VTI ratio to predict fluid responsiveness in critically ill patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fluid responsiveness
Key secondary outcomes
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
Critically ill patients with at least one of the clinical findings of tissue hypoperfusion for whom the attending physicians decided to conduct rapid fluid challenge test in the absence of contraindication for fluid infusion will be include in this study. Clinical signs of tissue hypoperfusion are defined as follows. a) Systolic blood pressure < 90 mm Hg (or a decrease < 50 mm Hg in previously hypertensive patients) or the need for vasopressive drugs (dopamine or norepinephrine); b) urine output < 0.5 mL/kg/hr for in 2 hrs; c) tachycardia (heart rate > 100/min); or d) presence of skin mottling
Key exclusion criteria
The patients whose TAPSE and LVOT VTI cannot be obtained on transthoracic echocardiogram (TTE) will be also excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Norisue |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Emergency and critical care medicine
Zip code
223-0064
Address
Yokohama, Japan
TEL
047-351-3101
norisue.yasuhiro@gmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Norisue |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Emergency and critical care medicine
Zip code
223-0064
Address
Yokohama, Japan
TEL
047-351-3101
Homepage URL
norisue.yasuhiro@gmail.com
Sponsor or person
Institute
No sponsor
Institute
Department
Personal name
Funding Source
Organization
No funding
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
Tokyo Bay Urayasu Ichikawa Medical Center
Address
3-4-32 Todaijima,
Tel
08058959696
norisue.yasuhiro@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 03 | 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
| 2016 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 01 | Day |
Other
Other related information
No other information yet
Management information
Registered date
| 2016 | Year | 09 | Month | 03 | Day |
Last modified on
| 2019 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027546
