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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023921
Receipt No. R000027545
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
Date of disclosure of the study information 2016/09/03
Last modified on 2016/09/03

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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 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
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 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
Last name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Norisue
Organization Tokyo Bay Urayasu Ichikawa Medical Center
Division name Emergency and critical care medicine
Zip code
Address 3-4-32 Todaijima Urayasu City, Chiba, Japan 2790001
TEL 047-351-3101
Email norisue.yasuhiro@gmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Yasuhiro Norisue
Organization Tokyo Bay Urayasu Ichikawa Medical Center
Division name Emergency and critical care medicine
Zip code
Address 3-4-32 Todaijima Urayasu City, Chiba, Japan 2790001
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
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

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
2016 Year 09 Month 03 Day


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

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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