Effect of Goal-directed Fluid Therapy on Postoperative Complications

February 21, 2022 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

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

  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

375

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Laparoscopic hepatobiliary or pancreatic surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

May 24, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EV1000

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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