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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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ClinicalTrials.gov Identifier: NCT02841046
Recruitment Status : Completed
First Posted : July 21, 2016
Results First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Lin Yang, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
Fluid Therapy Device: cardiac index Device: Stroke Volume Variation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 27, 2016
Actual Primary Completion Date : May 18, 2019
Actual Study Completion Date : June 25, 2019

Arm Intervention/treatment
group cardiac index
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 .
Device: cardiac index
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.

Experimental: group Stroke Volume Variation
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 .
Device: Stroke Volume Variation
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 Measures :
  1. Number of Days Needed for Anal Exsufflation After Surgery [ Time Frame: up to 8 weeks ]
    record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery


Secondary Outcome Measures :
  1. the Incidence of Adverse Cardiovascular Events [ Time Frame: during the surgery ]
    including hypertension,hypotension,tachycardia,bradycardia

  2. Oxygen Delivery(DO2) [ Time Frame: during the surgery ]
    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.

  3. Oxygen Consumption(VO2) [ Time Frame: during the surgery ]
    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.

  4. Oxygen Extraction Rate(ERO2) [ Time Frame: during the surgery ]
    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.

  5. Number of Days in Hospital [ Time Frame: up to 10 weeks ]
    The number of days from the admission to hospital until the discharge from hospital


Other Outcome Measures:
  1. The Volume of Crystalloid Infusion [ Time Frame: during the surgery ]
    Volume of crystalloid infusion in milliliter.

  2. The Volume of Colloid Infusion [ Time Frame: during the surgery ]
    Volume of colloid infusion in milliliter.

  3. Complication After Surgery [ Time Frame: up to 8 weeks ]
    From the end of surgery to the time of discharge from hospital.including ileus,abdominal infection,infection of incisional wound,pulmonary infection



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841046


Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Chair: Shu HaiHua, doctor First Affiliated Hospital, Sun Yat-Sen University
  Study Documents (Full-Text)

Documents provided by Lin Yang, First Affiliated Hospital, Sun Yat-Sen University:
Publications of Results:

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Responsible Party: Lin Yang, Attending Physician, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02841046    
Other Study ID Numbers: [2014]No.60
First Posted: July 21, 2016    Key Record Dates
Results First Posted: March 3, 2020
Last Update Posted: March 3, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It should be discuss.
Supporting Materials: Study Protocol
Keywords provided by Lin Yang, First Affiliated Hospital, Sun Yat-Sen University:
stroke volume variation
cardiac index
non-severe patients
gastrointestinal surgery
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases