UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000026946
Receipt No. R000030907
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 who have spontaneously breathing and assisted with mechanical ventilation.
Date of disclosure of the study information 2017/04/11
Last modified on 2019/10/13 (Ver. 7)

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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 who have spontaneously breathing and assisted with mechanical ventilation.
Acronym TAPSE/LVOT-VTI ratio and fluid responsiveness in patients on mechanical ventilation who have spontaneous breathing
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 who have spontaneously breathing and assisted with mechanical ventilation.
Scientific Title:Acronym TAPSE/LVOT-VTI ratio and fluid responsiveness in patients on mechanical ventilation who have spontaneous breathing
Region
Japan

Condition
Condition Critically ill patients who are mechanically ventilated and have spontaneous breathing
Classification by specialty
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 mechanically ventilated critically ill patients who have spontaneous breathing.
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 who have spontaneous breathing 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 with suspected acute coronary syndrome, known coronary artery disease or patients after cardiac open surgery within a month will be excluded. 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 Pulmonary and Critical Care Medicine
Zip code 279-0001
Address 3-4-32 Todaijima, Urayasushi, Chiba, 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 Pulmonary and Critical Care Medicine
Zip code 279-0001
Address 3-4-32 Todaijima, Urayasushi, Chiba, Japan
TEL 080-5895-9696
Homepage URL
Email norisue.yasuhiro@gmail.com

Sponsor
Institute Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department

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 Yokohama, Japan
Tel 047-351-3101
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
2017 Year 04 Month 11 Day

Related information
URL releasing protocol unpublished
Publication of results Unpublished

Result
URL related to results and publications unpublished
Number of participants that the trial has enrolled 109
Results 
Results: The area under the curve (AUC) to predict positive fluid responsiveness was 0.744 (95% confidence interval [CI] 0.65 to 0.84) with TAPSE/SV. The AUC to predict adverse fluid responsiveness was 0.783 (95% CI 0.66 to 0.91) with TAPSE/SV.
Results date posted
2019 Year 10 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Critically ill patients
Participant flow 
Critically ill patients, including those who had already received volume expansion before inclusion in the study, were eligible for the study if the attending physician decided to conduct a rapid fluid challenge test for signs of tissue hypoperfusion.
Adverse events 
None
Outcome measures 
Fluid responsiveness
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
2016 Year 08 Month 17 Day
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2018 Year 04 Month 01 Day
Date of closure to data entry
2018 Year 10 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2017 Year 04 Month 11 Day
Last modified on
2019 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030907