Effect of Goal-directed Fluid Therapy on Postoperative Complications

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169998
• Other study ID #: EV1000
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Laparoscopic hepatobiliary or pancreatic surgery

Exclusion Criteria:

• Patients who do not consent to participation in the study

• Pregnant women, breastfeeding women

Related Conditions & MeSH terms

• Liver Diseases
• Pancreas Disease
• Pancreatic Diseases
• Postoperative Complications

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary complication		Postoperative 90 day
Primary	Wound complication		Postoperative 90 day
Primary	Acute kidney injury		Postoperative 90 day
Primary	Delirium		Postoperative 90 day
Primary	Deep vein thrombosis		Postoperative 90 day
Primary	Myocardiac infarction		Postoperative 90 day
Primary	Stroke		Postoperative 90 day
Primary	Sepsis		Postoperative 90 day
Primary	Urinary tract infection		Postoperative 90 day
Primary	Death		Postoperative 90 day