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Quantitative analysis for body fluid status during neurosurgery

Status Approved

  • First Submitted Date

    2019/11/12

  • Registered Date

    2019/11/19

  • Last Updated Date

    2019/11/12

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
    KCT0004451
    Unique Protocol ID CNUHH-2019-186
    Public/Brief Title Quantitative analysis for body fluid status during neurosurgery
    Scientific Title Quantitative analysis for body fluid status during neurosurgery
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CNUHH-2019-186
    Approval Date 2019-11-06
    Institutional Review Board Name Institutional review board of Chonnam National University Hwasun Hospital
    Institutional Review Board Address 322, Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do
    Institutional Review Board Telephone 061-379-7598
    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 Seongheon Lee
    Title Assistant professor
    Telephone +82-61-379-8546
    Affiliation Chonnam National University Hospital Hwasun Hospital
    Address 322 Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do, Korea
    Contact Person for Public Queries
    Name Seongheon Lee
    Title Assistant professor
    Telephone +82-61-379-8546
    Affiliation Chonnam National University Hospital Hwasun Hospital
    Address 322 Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do, Korea
    Contact Person for Updating Information
    Name Seongheon Lee
    Title Assistant professor
    Telephone +82-61-379-8546
    Affiliation Chonnam National University Hospital Hwasun Hospital
    Address 322 Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do, Korea
  • 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 Not yet recruiting
    Date of First Enrollment 2019-11-18 Anticipated
    Target Number of Participant 20
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Chonnam National University Hospital Hwasun Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2019-11-18 ,
  • 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 Chonnam National University Hospital Hwasun Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chonnam National University Hospital Hwasun Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    For successful fluid therapy, it is helpful to quantify how the administered fluid is distributed and eliminated from the body. Recently introduced fluid kinetics can be used to analyze the disposition of infusion fluids. Moreover, population non-linear mixed effect modeling of fluid kinetics could consider inter-individual variability of surgical patients with different physical characteristics when administering fluids.  The inclusion of covariates, such as body weight and blood pressure, in the parameters of the fluid kinetic model may enable the individualized administration of fluids to patients.The aim of this study was to characterize the volume kinetics of fluid administered  in patients undergoing neurosurgery by nonlinear mixed effects modeling.
  • 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 Prospective  
    Target Number of Participant 20
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Patients undergoing neurosurgery

    Cohort/Group Description

    Measurements of hemoglobin in patients undergoing neurosurgery with craniotomy under general anesthesia
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    adult patients who will have elective neurosurgery under general anesthesia
    Sampling Method
    Non-probability sampling (purposive sampling)
    Condition(s)/Problem(s)    Not Applicable-Etc 

    neurosurgery
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~90Year

    Description

    adult patients who will have elective neurosurgery with craniotomy under general anesthesia
    Exclusion Criteria
    -American society of anesthesiologists (ASA) Physical status >=3 
    -Preoperative hemoglobin < 10 g/dl
    -Blood transfusion before surgery (<24h)
    -Use of mannitol before surgery
    -Use of diuretics before surgery
    -Anticipated massive bleeding during surgery
    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 Pharmacokinetics
    Primary Outcome(s) 1
    Outcome
    Hemoglobin
    Timepoint
    Hemoglobin measurements from induction of anesthesia to the end of surgery (7-14 times)
    Secondary Outcome(s) 1
    Outcome
    Pharmacokinetic parameters and covariate of non-linear mixed effect model
    Timepoint
    After population pharmacokinetic analysis
  • 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 No
  • 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 No
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