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

Goal-directed Fluid Therapy Clinical Trial

Official title:

Department of Anesthesiology, Beijing Tong Ren Hospital Capital Medical University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940144
• Other study ID #: PX2018007
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: February 2, 2021

Study information

• Verified date: March 2023
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Goal-directed Fluid Therapy

Intervention

Device:
• the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device
Stroke volume variation (SVV)-guided fluid therapy

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	GI function	number of participants with I-FEED score >6	from the end of surgery to 30 days after surgery
Secondary	mortality	death after surgery	from the end of surgery to 1 year after surgery
Secondary	postoperative pain score	VAS for pain :0 no pain and 10 for worst pain	1 day, 3 days and 5 days after surgery
Secondary	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
Secondary	Postoperative complications	number of any complications after surgery	from end of surgery to 30 days after surgery