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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

Tracking Information
First Submitted Date  ICMJE July 8, 2016
First Posted Date  ICMJE July 21, 2016
Results First Submitted Date  ICMJE February 18, 2020
Results First Posted Date  ICMJE March 3, 2020
Last Update Posted Date March 3, 2020
Actual Study Start Date  ICMJE July 27, 2016
Actual Primary Completion Date May 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
  • the Incidence of Adverse Cardiovascular Events [ Time Frame: during the surgery ]
    including hypertension,hypotension,tachycardia,bradycardia
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 19, 2016)
  • The Volume of Crystalloid Infusion [ Time Frame: during the surgery ]
    Volume of crystalloid infusion in milliliter.
  • The Volume of Colloid Infusion [ Time Frame: during the surgery ]
    Volume of colloid infusion in milliliter.
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Goal-directed Therapy Guided by Stroke Volume Variation and Cardiac Index in Non-severe Surgical Patients
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fluid Therapy
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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 .
    Intervention: Device: cardiac index
  • 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 .
    Intervention: Device: Stroke Volume Variation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 25, 2019
Actual Primary Completion Date May 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02841046
Other Study ID Numbers  ICMJE [2014]No.60
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: It should be discuss.
Supporting Materials: Study Protocol
Responsible Party Lin Yang, First Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE First Affiliated Hospital, Sun Yat-Sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Shu HaiHua, doctor First Affiliated Hospital, Sun Yat-Sen University
PRS Account First Affiliated Hospital, Sun Yat-Sen University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP