Effect of Goal-directed Fluid Therapy on Postoperative Complications

NCT ID: NCT03169998

Last Updated: 2022-02-22

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

Total Enrollment

375 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2021-12-31

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

Detailed Description

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Conditions

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Liver Diseases Pancreas Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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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.

EV1000 platform

Intervention Type 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).

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.

No interventions assigned to this group

Interventions

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EV1000 platform

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).

Intervention Type DEVICE

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Seok Na

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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EV1000

Identifier Type: -

Identifier Source: org_study_id

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