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The correlation between the change in thoracic fluid content and the change in patient body weight in Fontan procedure

Status Approved

  • First Submitted Date

    2016/08/23

  • Registered Date

    2016/09/19

  • Last Updated Date

    2016/09/06

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002062
    Unique Protocol ID KUH1160103
    Public/Brief Title The correlation between the change in thoracic fluid content and the change in patient body weight in Fontan procedure
    Scientific Title The correlation between the change in thoracic fluid content and the change in patient body weight in Fontan procedure
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KUH1160103
    Approval Date 2016-08-03
    Institutional Review Board Name Institutional Review Board of Konkuk University Medical Center
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Woon-Seok Kang
    Title
    Telephone
    Affiliation Konkuk University Medical Center
    Address 120-1 Neungdongro Gwangjingu Seoul
    Contact Person for Public Queries
    Name Woon-Seok Kang
    Title
    Telephone
    Affiliation Konkuk University Medical Center
    Address 120-1 Neungdongro Gwangjingu Seoul
    Contact Person for Updating Information
    Name Woon-Seok Kang
    Title
    Telephone
    Affiliation Konkuk University Medical Center
    Address 120-1 Neungdongro Gwangjingu Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2016-08-05 Actual
    Target Number of Participant 25
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Konkuk University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2016-08-05 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Konkuk University Medical Center
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Konkuk University Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Determination of exact patients’ volume status and appropriate strategy for fluid management during pediatric cardiac surgery are critical factors to obtain stable hemodynamic status and better clinical outcome. It is even more important than in adult cardiac surgery because the large amounts of fluid shifts compared to the patient’s small body surface area can occur. In addition, the inflammatory reactions by the operation of cardiopulmonary bypass (CPB) can aggravate the patient’s unstable hemodynamic state.
    Traditional method to evaluate volume status in adult patients is measurement of central venous pressure (CVP) or pulmonary capillary wedge pressure (PCWP). In pediatric patients, CVP also has been widely used to estimate intravascular volume status. However, its use as a marker of exact volume status is inappropriate because of the various factors to affect the accuracy such as venous capacitance, cardiac chamber compliance, cardiac valve competence and pulmonary artery pressure. In addition, the patient’s small size or aberrant anatomy make difficulty to insert a pulmonary artery catheter for PCWP measurement in pediatric patients who have congenital heart disease, and this procedure has a high risk of complications such as rupture of pulmonary artery. 
    In the pediatric patients undergoing Fontan procedure, it is more difficult to evaluate the patient’s exact volume status by using CVP measurement because the value of CVP indicates the pulmonary arterial pressure in post-operative period. Therefore, if there is good indicator of patients’ volume status, it will be useful for fluid management in the patients undergoing Fontan procedure. 
    The values of thoracic fluid content (TFC) and percentage change in TFC compared with baseline (TFCd0%) derived by the bioreactance technique using non-invasive cardiac output monitoring (NICOM) device already showed good correlation with the amount of fluid removal in patients undergoing hemodialysis and with intraoperative fluid balance in patients undergoing pediatric cardiac surgery. Therefore, we hypothesized that TFC or TFCd0% might be also a useful indicator for fluid management in pediatric patients undergoing Fontan procedure.  
     The aim of this study was to evaluate the utility of TFC or TFCd0% in intraoperative fluid management and its clinical application. Thus, the values of TFC, changes in TFC, intraoperative fluid balance, and changes in body weight were analyzed to evaluate the correlations among them.
    
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Retrospective  
    Target Number of Participant 25
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    medical records including anesthetic and operative records of patients who had elective Fontan procedure due to congenital functional single ventricle

    Cohort/Group Description

    medical records including anesthetic and operative records of patients who had elective Fontan procedure due to congenital functional single ventricle from april 2011 to december 2015 - hemodynamic variables measured by non-invasive and invasive monitoring, various variables such as cardiac output, stroke volume, stroke volume variation, thoracic fluid content measured by non-invasive cardiac output monitoring, patients' body weight and intraoperative fluid balance which were recorded at two time points (after anesthetic induction and just before transfer to SICU)
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    patients who had elective Fontan procedure due to congenital functional single ventricle in Konkuk University Medical Center from April 2011 to December 2015
    Sampling Method
    By using non-probablity sampling method, patients who had elective Fontan procedure due to congenital functional single ventricle in Konkuk University Medical Center from April 2011 to December 2015 were reviewed retrospectively
    Condition(s)/Problem(s) * (Q00-Q99)Congenital malformations, deformations and chromosomal abnormalities 
       (Q24.9)Congenital malformation of heart, unspecified 
    Rare Disease Yes
    Inclusion Criteria

    Gender

    Both

    Age

    1Year~4Year

    Description

    patients who had elective Fontan procedure due to congenital functional single ventricle in Konkuk University Medical Center from April 2011 to December 2015 
    Exclusion Criteria
    incomplete medical record
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Thoracic fluid content
    Timepoint
    at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU 
    Primary Outcome(s) 2
    Outcome
    Body weight of patient
    Timepoint
    at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU 
    Primary Outcome(s) 3
    Outcome
    intraoperative fluid balance (Input/Output) 
    Timepoint
    just before departure from the operating room to the ICU 
    Primary Outcome(s) 4
    Outcome
    TFCd0%
    Timepoint
    at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU 
    Secondary Outcome(s) 1
    Outcome
    Mean arterial blood pressure
    Timepoint
    at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU 
    Secondary Outcome(s) 2
    Outcome
    Heart rate
    Timepoint
    at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU 
    Secondary Outcome(s) 3
    Outcome
    central venous pressure
    Timepoint
    at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU 
    Secondary Outcome(s) 4
    Outcome
    Cardiac output and cardiac index
    Timepoint
    at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU 
    Secondary Outcome(s) 5
    Outcome
    Stroke volume variation
    Timepoint
    at the time of first measurement of NICOM data after anesthesia induction and just before departure from the operating room to the ICU 
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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