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Comparison of 6% Hydroxyethyl Starch 130/0.4 With 5% Albumin as Priming Solution for Cardiopulmonary Bypass

Primary Purpose

Mitral Valvular Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
6% hydroxyethyl starch 130/0.4 and 5% albumin
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valvular Heart Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mitral valvular heart disease

Exclusion Criteria:

  • Status of Infection
  • Re-operation
  • Liver failure
  • Renal disease
  • Administration of steroid

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    HES 130/0.4

    5% albumin

    Arm Description

    Outcomes

    Primary Outcome Measures

    the pure effect of priming solutions

    Secondary Outcome Measures

    Full Information

    First Posted
    September 16, 2009
    Last Updated
    February 2, 2012
    Sponsor
    Yonsei University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00978588
    Brief Title
    Comparison of 6% Hydroxyethyl Starch 130/0.4 With 5% Albumin as Priming Solution for Cardiopulmonary Bypass
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2008 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    August 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yonsei University

    4. Oversight

    5. Study Description

    Brief Summary
    Comparison of 6% hydroxyethyl starch 130/0.4 with 5% albumin as priming solution for cardiopulmonary bypass

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mitral Valvular Heart Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HES 130/0.4
    Arm Type
    Experimental
    Arm Title
    5% albumin
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    6% hydroxyethyl starch 130/0.4 and 5% albumin
    Intervention Description
    Injection of 6% hydroxyethyl starch 130/0.4 and 5% albumin as priming solution for cardiopulmonary bypass
    Primary Outcome Measure Information:
    Title
    the pure effect of priming solutions
    Time Frame
    after CPB

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mitral valvular heart disease Exclusion Criteria: Status of Infection Re-operation Liver failure Renal disease Administration of steroid
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Young Lan Kwak, M.D.,PhD,
    Organizational Affiliation
    Severance Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of 6% Hydroxyethyl Starch 130/0.4 With 5% Albumin as Priming Solution for Cardiopulmonary Bypass

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