UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011808 |
|---|---|
| Receipt number | R000013787 |
| Scientific Title | Prediction of fluid responsiveness in patients after congenital cardiac surgery using pleth variability index |
| Date of disclosure of the study information | 2013/09/20 |
| Last modified on | 2015/02/12 21:02:12 |
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Basic information
Public title
Prediction of fluid responsiveness in patients after congenital cardiac surgery using pleth variability index
Acronym
Prediction of fluid responsiveness in patients after congenital cardiac surgery using pleth variability index
Scientific Title
Prediction of fluid responsiveness in patients after congenital cardiac surgery using pleth variability index
Scientific Title:Acronym
Prediction of fluid responsiveness in patients after congenital cardiac surgery using pleth variability index
Region
| Japan |
Condition
Condition
Patients after closure of ventricular septal defect
Classification by specialty
| Cardiology | Anesthesiology | Operative medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to explore prediction of fluid responsiveness after congenital cardiac surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pleth variability index
Pulse presssure variation
Systolic pressure variation
Respiratory variation of peak aortic velocity of the left ventricular outflow tract
The Aortic velocity time integral of the left ventricular outflow tract
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
| 2 | months-old | <= |
Age-upper limit
| 60 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients after closure of ventricular septal defect
Key exclusion criteria
The exclusion criteria ruled out the patients with arrhythmia, preoperative severe left ventricular systolic dysfunction, postoperative persistent pulmonary hypertension and left to right shunt.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Umegaki Osamu |
Organization
Osaka medical college
Division name
Department of intensive care unit
Zip code
Address
2-7 Daigakumachi, Takatsuki, Osaka, 569-8686, JAPAN
TEL
0726831221
oumegaki@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kusaka Yusuke |
Organization
Osaka medical college
Division name
Department of intensive care medicen
Zip code
Address
2-7 Daigakumachi, Takatsuki, Osaka, 569-8686, JAPAN
TEL
0726831221
Homepage URL
Y.kusaka1978@gmail.com
Sponsor or person
Institute
Department of intensive care unit, Osaka medical college
Institute
Department
Personal name
Funding Source
Organization
Department of intensive care unit, Osaka medical college
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
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
| 2013 | Year | 09 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After ICU admission, volume loading (6% hydroxyethyl starch 10 ml/kg) is performed to the patients after repair of ventricular septal defect. We measure following parameters before and after volume loading; pleth variability index (PVI), pulse pressure variation, systolic pressure variation (SPV), respiratory variation in aortic flow peak velocity, and aortic velocity time integral (VTI). Patients showing an increase in VTI of 15% or more, after volume loading, are classified as responders. Patients showing an increase in VTI of 15% or less are classified as non-responders. Receiver-operating characteristics (ROC) curves are generated for PVI, PPV, SPV, respiratory variation in aortic flow peak velocity and area under the ROC curves are calculated and compared.
Management information
Registered date
| 2013 | Year | 09 | Month | 19 | Day |
Last modified on
| 2015 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013787
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
