Clinical trial NCT02841046: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Therapy
Keywords: stroke volume variation
cardiac index
non-severe patients
gastrointestinal surgery
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Number of Days Needed for Anal Exsufflation After Surgery
timeFrame: up to 8 weeks
Secondary outcomes:
measure: the Incidence of Adverse Cardiovascular Events
timeFrame: during the surgery
measure: Oxygen Delivery（DO2）
timeFrame: during the surgery
measure: Oxygen Consumption（VO2）
timeFrame: during the surgery
measure: Oxygen Extraction Rate（ERO2）
timeFrame: during the surgery
measure: Number of Days in Hospital
timeFrame: up to 10 weeks
Other outcomes:
measure: The Volume of Crystalloid Infusion
timeFrame: during the surgery
measure: The Volume of Colloid Infusion
timeFrame: during the surgery
measure: Complication After Surgery
timeFrame: up to 8 weeks
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Shu HaiHua, doctor
role: STUDY_CHAIR
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