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

Capital Medical University

Status: Completed

Conditions: Goal-directed Fluid Therapy

Treatments: Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device

Study type: Interventional

Funder types: Other

Identifiers

NCT03940144

PX2018007

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

goal-directed fluid therapy

Experimental group

Description:

Stroke Volume variation (SVV)-guided fluid therapy

Treatment:

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

Conventional fluid therapy

Active Comparator group

Description:

Conventional fluid therapy such as CVP and MAP guided fluid therapy

Treatment:

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