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

Not Applicable

Completed

• Conditions: Fluid Therapy
• Interventions: Device: Stroke Volume Variation; Device: cardiac index

• Registration Number: NCT02841046
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-21
• Study Start: 2016-07-27
• Primary Completion: 2019-05-18
• Study Completion: 2019-06-25
• Status Verified: 2020-02
• Results First Submitted: 2020-02-18
• Results First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Results First Posted: 2020-03-03
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group Stroke Volume Variation	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 .
group cardiac index	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 .

Primary Outcome Measures

Name	Time	Method
Number of Days Needed for Anal Exsufflation After Surgery	up to 8 weeks	record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery

Secondary Outcome Measures

Name	Time	Method
Number of Days in Hospital	up to 10 weeks	The number of days from the admission to hospital until the discharge from hospital
Oxygen Consumption（VO2）	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）	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.
the Incidence of Adverse Cardiovascular Events	during the surgery	including hypertension,hypotension,tachycardia,bradycardia
Oxygen Delivery（DO2）	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.