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NCT Number: NCT02841046

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

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.

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Key information

Conditions

Fluid Therapy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac index

Device

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.

Stroke Volume Variation

Device

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 21, 2016
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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