Effect of Goal-directed Fluid Therapy on Postoperative Complications

NCT03169998 | Completed DMC

• 1 other identifier: EV1000
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

Liver Diseases; Pancreas Disease

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

GDFT group

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

Control group

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.

Interventions

EV1000 platform DEVICE

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).

GDFT group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is to be conducted in patients scheduled with laparoscopic hepatobiliary or pancreatic surgery, who are at risk either for taking 2 hours or more in surgery or to lose blood of 1000 ml or more.

You may qualify if:

• Laparoscopic hepatobiliary or pancreatic surgery

You may not qualify if:

• Patients who do not consent to participation in the study
• Pregnant women, breastfeeding women

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Liver Diseases; Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: January 1, 2017
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

KR (1)