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Completed

NCT Number: NCT03169998

Effect of Goal-directed Fluid Therapy on Postoperative Complications

* 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

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Key information

Conditions

Liver Diseases Digestive System Diseases Pancreas Disease Pancreatic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Laparoscopic hepatobiliary or pancreatic surgery

Exclusion criteria

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

Treatment and study plan

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).

Primary outcomes

  1. Pulmonary complication

    Time frame: Postoperative 90 day

  2. Wound complication

    Time frame: Postoperative 90 day

  3. Acute kidney injury

    Time frame: Postoperative 90 day

  4. Delirium

    Time frame: Postoperative 90 day

  5. Deep vein thrombosis

    Time frame: Postoperative 90 day

  6. Myocardiac infarction

    Time frame: Postoperative 90 day

  7. Stroke

    Time frame: Postoperative 90 day

  8. Sepsis

    Time frame: Postoperative 90 day

  9. Urinary tract infection

    Time frame: Postoperative 90 day

  10. Death

    Time frame: Postoperative 90 day

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 30, 2017
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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