search
Back to results

Stroke Volume Variation- Guided Hemodynamic Therapy Versus Oxygen Extraction Ratio-guided Hemodynamic Therapy

Primary Purpose

Goal-directed Fluid Therapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SVV-GDHT
O2ER-GDHT
conventional care
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Goal-directed Fluid Therapy focused on measuring stroke volume variation, oxygen extraction ratio, goal-directed fluid therapy, laparoscopic gastrointestinal surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18~80 years
  2. ASA I~III
  3. Patients undergoing elective major laparoscopic gastrointestinal oncological surgery.Procedures were considered major if listed for resection cancer with tumor debulking, staging or reconstruction with a risk for significant surgical blood loss.

Exclusion Criteria:

  1. co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine >50 % or liver enzymes >50 % of normal values), and arrhythmias.
  2. less than 18 years
  3. pregnant or lactating woman
  4. patients undergoing emergency surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    SVV-GDHT

    O2ER-GDHT

    conventional care

    Arm Description

    SVV ≤12% and CI of at least 2.5 L•min-1•m-2 were required. 500 mL of crystalloids was infused during induction, followed by a 2 ml•kg-1•h-1continuous infusion. If SVV was higher than 12% for over 5 minutes, a 250 mL bolus of crystalloid was given. Another 250 ml bolus of colloid was administrated if SVV was still higher than 12% or SVV decreased over 10%. If CI value was below 2.5 L•min-1•m-2, inotropes were applied to reach this minimum CI, serving as a safety parameter to prevent patients from low cardiac output. If SVV and CI were within the target range but MAP was below 65 mmHg, norepinephrine was started. After the initial assessment, patients were reassessed every 5 minutes intraoperatively to maintain values according to the study algorithm

    the goal of O2ER is assessed every one hour to keep O2ER<27% which calculated by the following equation:(SaO2 - SvO2)/SaO2, when O2ER is greated than 27%, CVP lower than 10mmHg, 250ml colloid is given, otherwise, inotropes is given as CVP≥10mmHg.

    MAP was kept between 65 and 90 mmHg, CVP between 8 and 12 mmHg and urinary output more than 0.5 ml•kg-1•h-1. 500 ml of crystalloids was infused during induction, followed by a continuous infusion of crystalloids (4 ml•kg-1•h-1). If the MAP decreased below 65 mmHg, or if the CVP decreased below 8 mmHg, a 250 mL bolus of colloid was given after waiting 5 minutes if any one of the criteria was met. If the MAP decreased below 65 mmHg and remained unresponsive to fluids, norepinephrine or inotropes was given to maintain the MAP above 65 mmHg.

    Outcomes

    Primary Outcome Measures

    postoperative complication
    the number of patients with predefined moderate or major postoperative complications (pulmonary embolism, myocardial ischemia or infarction, arrhythmia, cardiac or respiratory arrest, limb or digital ischemia, cardiogenic pulmonary edema, acute respiratory distress syndrome, gastrointestinal bleeding, bowel infarction, anastomotic breakdown, paralytic ileus, acute psychosis, stroke, acute kidney injury, infection [source uncertain], urinary tract infection, surgical site infection, organ/space infection, bloodstream infection, nosocomial pneumonia, and postoperative hemorrhage

    Secondary Outcome Measures

    Length of hospital stay
    Length of stay was determined by the period from completion of surgery to discharge
    critical care-freedays
    numberof days alive and not in critical care
    mortality
    all cause mortality
    postoperative recovery quality
    QoR15, 0 :not at all , 10: most of time
    time to first tolerate of an oral diet
    time from the end of surgery and first tolerate of an oral diet
    time to first flatus
    duration between the end of surgery and first flatus

    Full Information

    First Posted
    July 24, 2022
    Last Updated
    February 1, 2023
    Sponsor
    Beijing Tongren Hospital
    Collaborators
    Beijing Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05487924
    Brief Title
    Stroke Volume Variation- Guided Hemodynamic Therapy Versus Oxygen Extraction Ratio-guided Hemodynamic Therapy
    Official Title
    Stroke Volume Variation- Guided Hemodynamic Therapy Versus Oxygen Extraction Ratio-guided Hemodynamic Therapy on Outcomes Following Laparoscopic Gastrointestinal Cancer Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Tongren Hospital
    Collaborators
    Beijing Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The FloTrac/Vigileo is a minimal invasive device assessing flow based hemodynamic parameters by pulse contour analysis based on the radial artery pressure signal. This method gained popularity as it is minimally invasive compared to esophageal Doppler or pulmonary artery catheter insertion and provides continuous beat-to-beat data. The previous study with 110 patients found that that GDHT guided by stroke volume variation (SVV) using the FloTrac/Vigileo device was associated with a reduced length of hospital stay and a lower incidence of POGD in major abdominal oncological surgery. However, no difference was found in the incidence of postoperative complications between the two groups, lack of statistical power could be a limitation to demonstrate the true association. Therefore, further prospective trials are needed to address this issue. The use of early and efficient therapeutic strategies able to detect and to treat potential triggers of organ failures, such as tissue hypoperfusion, is particularly important. If hypoperfusion is not adequately managed, tissue hypoxia could occur, resulting from an impairment of the adaptive mechanisms of myocardial contractile function, under the influence of inflammatory mediators, and the peripheral tissues will then increase their oxygen extraction (O2ER). AS such, GDHT guided by O2ER may be appropriate to monitor GDHT strategies because it reflects the balance between oxygen delivery and consumption. Therefore, the investigators performed this single-center, randomized, controlled trial to investigate whether GDHT guided by SVV using FloTrac/Vigileo monitor and GDHT guided by O2ER would reduce incidence of postoperative complication and shorten the length of hospital stay, compared with a standard conventional fluid therapy in low-to-moderate risk patients undergoing major laparoscopic gastrointestinal oncological surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Goal-directed Fluid Therapy
    Keywords
    stroke volume variation, oxygen extraction ratio, goal-directed fluid therapy, laparoscopic gastrointestinal surgery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    610 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SVV-GDHT
    Arm Type
    Experimental
    Arm Description
    SVV ≤12% and CI of at least 2.5 L•min-1•m-2 were required. 500 mL of crystalloids was infused during induction, followed by a 2 ml•kg-1•h-1continuous infusion. If SVV was higher than 12% for over 5 minutes, a 250 mL bolus of crystalloid was given. Another 250 ml bolus of colloid was administrated if SVV was still higher than 12% or SVV decreased over 10%. If CI value was below 2.5 L•min-1•m-2, inotropes were applied to reach this minimum CI, serving as a safety parameter to prevent patients from low cardiac output. If SVV and CI were within the target range but MAP was below 65 mmHg, norepinephrine was started. After the initial assessment, patients were reassessed every 5 minutes intraoperatively to maintain values according to the study algorithm
    Arm Title
    O2ER-GDHT
    Arm Type
    Experimental
    Arm Description
    the goal of O2ER is assessed every one hour to keep O2ER<27% which calculated by the following equation:(SaO2 - SvO2)/SaO2, when O2ER is greated than 27%, CVP lower than 10mmHg, 250ml colloid is given, otherwise, inotropes is given as CVP≥10mmHg.
    Arm Title
    conventional care
    Arm Type
    Active Comparator
    Arm Description
    MAP was kept between 65 and 90 mmHg, CVP between 8 and 12 mmHg and urinary output more than 0.5 ml•kg-1•h-1. 500 ml of crystalloids was infused during induction, followed by a continuous infusion of crystalloids (4 ml•kg-1•h-1). If the MAP decreased below 65 mmHg, or if the CVP decreased below 8 mmHg, a 250 mL bolus of colloid was given after waiting 5 minutes if any one of the criteria was met. If the MAP decreased below 65 mmHg and remained unresponsive to fluids, norepinephrine or inotropes was given to maintain the MAP above 65 mmHg.
    Intervention Type
    Other
    Intervention Name(s)
    SVV-GDHT
    Intervention Description
    GDHT guided by SVV using Flotra/Vigileo monitor
    Intervention Type
    Other
    Intervention Name(s)
    O2ER-GDHT
    Intervention Description
    GDHT guided by O2ER
    Intervention Type
    Other
    Intervention Name(s)
    conventional care
    Intervention Description
    conventional fluid therapy without GDHT
    Primary Outcome Measure Information:
    Title
    postoperative complication
    Description
    the number of patients with predefined moderate or major postoperative complications (pulmonary embolism, myocardial ischemia or infarction, arrhythmia, cardiac or respiratory arrest, limb or digital ischemia, cardiogenic pulmonary edema, acute respiratory distress syndrome, gastrointestinal bleeding, bowel infarction, anastomotic breakdown, paralytic ileus, acute psychosis, stroke, acute kidney injury, infection [source uncertain], urinary tract infection, surgical site infection, organ/space infection, bloodstream infection, nosocomial pneumonia, and postoperative hemorrhage
    Time Frame
    30 days after surgery
    Secondary Outcome Measure Information:
    Title
    Length of hospital stay
    Description
    Length of stay was determined by the period from completion of surgery to discharge
    Time Frame
    from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery
    Title
    critical care-freedays
    Description
    numberof days alive and not in critical care
    Time Frame
    30 days after surgery
    Title
    mortality
    Description
    all cause mortality
    Time Frame
    all-cause mortality at 30 days following surgery; all-cause mortality at 180 days following surgery
    Title
    postoperative recovery quality
    Description
    QoR15, 0 :not at all , 10: most of time
    Time Frame
    1, 3, 7 days after surgery
    Title
    time to first tolerate of an oral diet
    Description
    time from the end of surgery and first tolerate of an oral diet
    Time Frame
    from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery
    Title
    time to first flatus
    Description
    duration between the end of surgery and first flatus
    Time Frame
    from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18~80 years ASA I~III Patients undergoing elective major laparoscopic gastrointestinal oncological surgery.Procedures were considered major if listed for resection cancer with tumor debulking, staging or reconstruction with a risk for significant surgical blood loss. Exclusion Criteria: co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine >50 % or liver enzymes >50 % of normal values), and arrhythmias. less than 18 years pregnant or lactating woman patients undergoing emergency surgery

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Stroke Volume Variation- Guided Hemodynamic Therapy Versus Oxygen Extraction Ratio-guided Hemodynamic Therapy

    We'll reach out to this number within 24 hrs