Effect of SVV-guided Fluid Therapy on Outcomes After Major Abdominal Surgery

Study Overview
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Brief Summary
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The investigators conduct this randomized assessor-blinded controlled trial to evaluate the effect of SVV-guided fluid therapy on postoperative morbidity and mortality in comparison with conventional fluid therapy after major abdominal surgery. Half of participants will receive GDFT perioperatively, and the others will receive conventional fluid therapy

Detailed Description
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Perioperative fluid management has been recognized as an important factor with an impact on postoperative recovery following major abdominal surgery. However, the optimal fluid management is difficult to achieve using standard parameters (e.g., heart rate [HR], blood pressure [BP], central venous pressure[CVP], or urine output) that poorly estimate preload and preload responsiveness. Goal-directed fluid therapy (GDFT) was proposed by introducing different hemodynamic variables into a dynamic perspective of individual fluid loading with or without vasoactive substances to reach predefined goal of optimal preload and/or oxygen delivery.There have been increasing numbers of studies evaluating the effect of perioperative GDFT on postoperative recovery following major abdominal surgery. However, the evidence for the beneficial effect of GDFT on postoperative recovery remains inconsistent.

Official Title
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Department of Anesthesiology, Beijing Tong Ren Hospital Capital Medical University

Conditions
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Goal-directed Fluid Therapy

Intervention / Treatment
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* Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (aged 18 to 80 years) ASA I III BMI:18 30kg／m2 Procedures were considered major if listed for resection of gastrointestinal, gynecologic, and urologic cancer with tumor debulking, staging or reconstruction with a risk for significant surgical blood loss Exclusion Criteria: Patients under 18 years, pregnant or lactating woman patients with esophageal or gastric surgical history co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine >50 % or liver enzymes >50 % of normal values), and arrhythmias-operative down staging using chemotherapy and/or radiation therapy patients undergoing emergency surgery patients with co-existing congestive heart failure; chronic lung disease; or renal or hepatic dysfunction (creatinine >50 % or liver enzymes >50 % of normal values), and arrhythmias

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: goal-directed fluid therapy guided by stroke volume variation and cardiac index using FloTrac/Vigileo monitor
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: goal-directed fluid therapy<br>Stroke Volume variation (SVV)-guided fluid therapy | Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device<br>* Stroke volume variation (SVV)-guided fluid therapy<br>|
| Active Comparator: Conventional fluid therapy<br>Conventional fluid therapy such as CVP and MAP guided fluid therapy | Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device<br>* Stroke volume variation (SVV)-guided fluid therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | from the end of surgery to discharge from hospital | from the end of surgery to discharge from hospital up to 30 days after surgery | 
| GI function | number of participants with I-FEED score >6 | from the end of surgery to 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | death after surgery | from the end of surgery to 1 year after surgery | 
| postoperative pain score | VAS for pain :0 no pain and 10 for worst pain | 1 day, 3 days and 5 days after surgery | 
| postoperative recovery quality | QoR-15 :quality of recovery score : 0 worst recovery quality and 150 for best recovery | 1 day, 3 days and 5 days after surgery | 
| Postoperative complications | number of any complications after surgery | from end of surgery to 30 days after surgery |