UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023921
Receipt number 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 2021/03/08 10:58:34

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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

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 or person

Institute

No sponsor

Institute

Department

Personal name



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

Value
https://center6.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