UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026946 |
|---|---|
| Receipt number | 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 09:58:18 |
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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
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
norisue.yasuhiro@gmail.com
Sponsor or person
Institute
Tokyo Bay Urayasu Ichikawa Medical Center
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
Yokohama, Japan
Tel
047-351-3101
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030907
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