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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011808
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email Y.kusaka1978@gmail.com

Sponsor
Institute Department of intensive care unit, Osaka medical college
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013787


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