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The Effect of Goal-directed Therapy Guided by Stroke Volume Variation and Cardiac Index in Non-severe Surgical Patients

Primary Purpose

Fluid Therapy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cardiac index
Stroke Volume Variation
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fluid Therapy focused on measuring stroke volume variation, cardiac index, non-severe patients, gastrointestinal surgery

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status of grade I-II
  • Cardiac function classification by NYHA of grade I
  • without high risk factors according to the revised Lee cardiac risk index:

    1. High-risk type of surgery
    2. Ischemic heart disease
    3. History of congestive heart failure
    4. History of cerebrovascular disease
    5. Insulin therapy for diabetes
    6. Preoperative serum creatinine > 2.0 mg/dl
  • undergoing gastrointestinal tumor surgery

Exclusion Criteria:

  • Patients under 18 years or above 55 years
  • patients with severe aortic regurgitation
  • patients with permanent cardiac arrhythmias
  • patients with intra-aortic balloon pump
  • patients with severe pulmonary disease
  • patients with hepatic or renal dysfunction
  • patients undergoing emergency surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    group cardiac index

    group Stroke Volume Variation

    Arm Description

    the treatment scheme of goal-directed fluid therapy(GDFT) use cardiac index(CI) as the primary judgment in group cardiac index,Patients in group cardiac index received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 .

    the treatment scheme of goal-directed fluid therapy(GDFT) use Stroke Volume Variation(SVV)and cardiac index(CI)as the primary judgment in group Stroke Volume Variation,Patients in group Stroke Volume Variation received a therapy with SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 .

    Outcomes

    Primary Outcome Measures

    Number of Days Needed for Anal Exsufflation After Surgery
    record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery

    Secondary Outcome Measures

    the Incidence of Adverse Cardiovascular Events
    including hypertension,hypotension,tachycardia,bradycardia
    Oxygen Delivery(DO2)
    oxygen delivery(DO2) in ml•min-1•m-2.Record the data of DO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.
    Oxygen Consumption(VO2)
    oxygen delivery(VO2) in ml•min-1•m-2.Record the data of VO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.
    Oxygen Extraction Rate(ERO2)
    oxygen extraction rate(ERO2) in percentage.Record the data of ERO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.
    Number of Days in Hospital
    The number of days from the admission to hospital until the discharge from hospital

    Full Information

    First Posted
    July 8, 2016
    Last Updated
    February 18, 2020
    Sponsor
    First Affiliated Hospital, Sun Yat-Sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02841046
    Brief Title
    The Effect of Goal-directed Therapy Guided by Stroke Volume Variation and Cardiac Index in Non-severe Surgical Patients
    Official Title
    The Application of Goal-directed Therapy With the Combination of Stroke Volume Variation and Cardiac Index as the Primary Judgment in Non-severe Patients Underwent Gastrointestinal Tumor Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 27, 2016 (Actual)
    Primary Completion Date
    May 18, 2019 (Actual)
    Study Completion Date
    June 25, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Affiliated Hospital, Sun Yat-Sen University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor. Fifty patients (ASA Ⅰ-Ⅱ, 26-55 years old, cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into two groups randomly: group C with CI as the primary judgment and group S with the combination of SVV and CI as the primary judgment.
    Detailed Description
    To evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor. Methods: Fifty patients (ASA Ⅰ-Ⅱ, 18-55 years old, cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into two groups randomly: group C with CI as the primary judgment and group S with the combination of SVV and CI as the primary judgment. Patients in group C received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 while SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 in group S. Indexes including MAP、HR、CVP、CI、SVV were recorded at the moment after anaesthetized (T1), when skin was incised (T2), when the intestina was anastomosed (T3) and after the abdomen was closed (T4). SaO2、ScvO2 and plasma lactic were determined at T1 and T4 and DO2,VO2 and ERO2 during the surgery were calculated .The volume of fluid, vasoactive drugs use, the incidence of adverse cardiovascular events, the convalescence of intestinal peristalsis, hospital stay and postoperative complications were recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fluid Therapy
    Keywords
    stroke volume variation, cardiac index, non-severe patients, gastrointestinal surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group cardiac index
    Arm Type
    Other
    Arm Description
    the treatment scheme of goal-directed fluid therapy(GDFT) use cardiac index(CI) as the primary judgment in group cardiac index,Patients in group cardiac index received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 .
    Arm Title
    group Stroke Volume Variation
    Arm Type
    Experimental
    Arm Description
    the treatment scheme of goal-directed fluid therapy(GDFT) use Stroke Volume Variation(SVV)and cardiac index(CI)as the primary judgment in group Stroke Volume Variation,Patients in group Stroke Volume Variation received a therapy with SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 .
    Intervention Type
    Device
    Intervention Name(s)
    cardiac index
    Intervention Description
    group cardiac index(CI) and group Stroke Volume Variation(SVV) are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment.
    Intervention Type
    Device
    Intervention Name(s)
    Stroke Volume Variation
    Intervention Description
    group cardiac index(CI) and group Stroke Volume Variation(SVV) are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment.
    Primary Outcome Measure Information:
    Title
    Number of Days Needed for Anal Exsufflation After Surgery
    Description
    record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery
    Time Frame
    up to 8 weeks
    Secondary Outcome Measure Information:
    Title
    the Incidence of Adverse Cardiovascular Events
    Description
    including hypertension,hypotension,tachycardia,bradycardia
    Time Frame
    during the surgery
    Title
    Oxygen Delivery(DO2)
    Description
    oxygen delivery(DO2) in ml•min-1•m-2.Record the data of DO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.
    Time Frame
    during the surgery
    Title
    Oxygen Consumption(VO2)
    Description
    oxygen delivery(VO2) in ml•min-1•m-2.Record the data of VO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.
    Time Frame
    during the surgery
    Title
    Oxygen Extraction Rate(ERO2)
    Description
    oxygen extraction rate(ERO2) in percentage.Record the data of ERO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.
    Time Frame
    during the surgery
    Title
    Number of Days in Hospital
    Description
    The number of days from the admission to hospital until the discharge from hospital
    Time Frame
    up to 10 weeks
    Other Pre-specified Outcome Measures:
    Title
    The Volume of Crystalloid Infusion
    Description
    Volume of crystalloid infusion in milliliter.
    Time Frame
    during the surgery
    Title
    The Volume of Colloid Infusion
    Description
    Volume of colloid infusion in milliliter.
    Time Frame
    during the surgery
    Title
    Complication After Surgery
    Description
    From the end of surgery to the time of discharge from hospital.including ileus,abdominal infection,infection of incisional wound,pulmonary infection
    Time Frame
    up to 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status of grade I-II Cardiac function classification by NYHA of grade I without high risk factors according to the revised Lee cardiac risk index: High-risk type of surgery Ischemic heart disease History of congestive heart failure History of cerebrovascular disease Insulin therapy for diabetes Preoperative serum creatinine > 2.0 mg/dl undergoing gastrointestinal tumor surgery Exclusion Criteria: Patients under 18 years or above 55 years patients with severe aortic regurgitation patients with permanent cardiac arrhythmias patients with intra-aortic balloon pump patients with severe pulmonary disease patients with hepatic or renal dysfunction patients undergoing emergency surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shu HaiHua, doctor
    Organizational Affiliation
    First Affiliated Hospital, Sun Yat-Sen University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    It should be discuss.
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    The Effect of Goal-directed Therapy Guided by Stroke Volume Variation and Cardiac Index in Non-severe Surgical Patients

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