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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2021-02-02

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

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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.

Conditions

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Goal-directed Fluid Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

goal-directed fluid therapy guided by stroke volume variation and cardiac index using FloTrac/Vigileo monitor

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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goal-directed fluid therapy

Stroke Volume variation (SVV)-guided fluid therapy

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Stroke volume variation (SVV)-guided fluid therapy

Conventional fluid therapy

Conventional fluid therapy such as CVP and MAP guided fluid therapy

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Stroke volume variation (SVV)-guided fluid therapy

Interventions

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

Stroke volume variation (SVV)-guided fluid therapy

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No