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

• Sponsor: Beijing Tongren Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03940144
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Actual Duration (Months): 33.1
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Complications	Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: goal-directed fluid therapy guided by stroke volume variation and cardiac index using FloTrac/Vigileo monitorgoal-directed fluid therapy guided by stroke volume variation and cardiac index using FloTrac/Vigileo monitor
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Care providers and investigators in the operating room could not be blinded due to the presence of the cardiac index trending monitor. The postoperative assessors were blinded to the allocation.
• Primary Purpose: Treatment
• Official Title: Department of Anesthesiology, Beijing Tong Ren Hospital Capital Medical University
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: Jan 3, 2021
• Actual Study Completion Date: Feb 2, 2021

Arms and Interventions

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, MAP and urine-output guided fluid therapy	Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device; Stroke volume variation (SVV)-guided fluid therapy

Outcome Measures

Primary Outcome Measures

1. postoperative morbidity [30 days after surgery]

   number of participants with at least one complication

2. GI function [30 days after surgery]

   number of participants with I-FEED score >6

3. length of hospital stay [30 days after surgery]

   from the end of surgery to discharge from hospital

Secondary Outcome Measures

1. mortality [from the end of surgery to 1 year after surgery]

   death after surgery

2. postoperative pain score [1 day, 3 days and 5 days after surgery]

   VAS for pain :0 no pain and 10 for worst pain

3. postoperative recovery quality [1 day, 3 days and 5 days after surgery]

   QoR :quality of recovery score : 0 worst recovery quality and 18 for best recovery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tongren Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Beijing Tongren Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: YANXIA SUN, staff anesthesiologist, Beijing Tongren Hospital
• ClinicalTrials.gov Identifier: NCT03940144
• Other Study ID Numbers: PX2018007
• First Posted: May 7, 2019
• Last Update Posted: Jul 5, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Postoperative Complications

Study Results

No Results Posted as of Jul 5, 2022