UMIN-CTR Clinical Trial

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 mechanically ventilated patients: a pilot study
Acronym	TAPSE / LVOT VTI ratio to predict fluid responsiveness
Scientific Title	Tricuspid annular plane systolic excursion / Left Ventricular Outflow Tract Velocity Time Integral (TAPSE / LVOT VTI) ratio to predict fluid responsiveness in mechanically ventilated patients: a pilot study
Scientific Title:Acronym	TAPSE / LVOT VTI ratio to predict fluid responsiveness
Region	Japan

Condition
Condition	Hemodynamic unstability
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Cardiology Pneumology 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
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Interventions/Control_4
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Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Mechanically ventilated 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	200

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
Email	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
Email	norisue.yasuhiro@gmail.com

Sponsor
Institute	No sponsor
Institute
Department

Funding Source
Organization	No funding
Organization
Division
Category of Funding Organization	Other
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	Yokohama, Japan
Tel	0473513101
Email	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	Preinitiation
Date of protocol fixation	2016 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date	2016 Year 09 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No other information yet

Management information
Registered date	2016 Year 09 Month 03 Day
Last modified on	2021 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027545