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

Department of Anesthesiology, Beijing Tong Ren Hospital Capital Medical University

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

Study Overview

• Status: Completed
• Conditions: Goal-directed Fluid Therapy
• Intervention / Treatment: Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult patients (aged 18 to 80 years)
2. ASA I~III
3. BMI:18~30kg／m2
4. 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:

1. Patients under 18 years,
2. pregnant or lactating woman
3. patients with esophageal or gastric surgical history
4. 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
5. patients undergoing emergency surgery
6. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Principal Investigator: Yanxia Sun, M.D., Beijing Tong Ren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): February 2, 2021

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: May 4, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: PX2018007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No