Effect of Goal-directed Fluid Therapy on Postoperative Complications

Study Overview
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Brief Summary
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It has been known that the recent application of a goal-directed fluid therapy (GDFT) to the intraoperative fluid infusion in patients contributes to decreasing the prevalence of postoperative complications and shortening the length of study in the intensive care unit as well as hospital stay compared with conventional methods. Laparoscopic surgery is in a trend that its application is being expanded recently, but there has been no report on the application of GDFT to laparoscopic surgery so far. To this end, this study aims to apply the intraoperative GDFT protocol in patients undergoing laparoscopic hepatobiliary or pancreatic surgery and to find out whether there is any difference in postoperative recovery and incidences of postoperative complications, by comparing with patients applied with the fluid therapy using existing conventional methods

Official Title
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The Effect of Goal-directed Fluid Therapy on Postoperative Complications in Patients Undergoing Laparoscopic Hepatobiliary or Pancreatic Surgery

Conditions
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Liver Diseases, Pancreas Disease

Intervention / Treatment
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* Device: EV1000 platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Laparoscopic hepatobiliary or pancreatic surgery Exclusion Criteria: Patients who do not consent to participation in the study Pregnant women, breastfeeding women

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GDFT group<br>The fluid infusion is to be performed, in accordance with GDFT protocol, on the basis of cardiac index (CI), stroke volume index(SVI) and stroke volume (SV) in addition to invasively measured arterial pressure by Vigilio / FloTrac Monitor. | Device: EV1000 platform<br>* a continuous arterial pressure monitoring was performed via EV1000/ FloTrac (Edwards Lifesciences, Irvine, CA, USA) (Fig 1) with the continuous monitoring of cardiac index (CI), stroke volume index (SVI) and stroke volume (SV).<br>|
| Control group<br>Patients in whom the surgery was conducted without the use of EV1000/ FloTrac monitoring among those who had undergone laparoscopic hepatobiliary or pancreatic surgery in the past. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary complication |  | Postoperative 90 day | 
| Wound complication |  | Postoperative 90 day | 
| Acute kidney injury |  | Postoperative 90 day | 
| Delirium |  | Postoperative 90 day | 
| Deep vein thrombosis |  | Postoperative 90 day | 
| Myocardiac infarction |  | Postoperative 90 day | 
| Stroke |  | Postoperative 90 day | 
| Sepsis |  | Postoperative 90 day | 
| Urinary tract infection |  | Postoperative 90 day | 
| Death |  | Postoperative 90 day |