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Effect of Goal-directed Fluid Therapy on Postoperative Complications

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ClinicalTrials.gov Identifier: NCT03169998
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital

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

Condition or disease Intervention/treatment
Liver Diseases Pancreas Disease Device: EV1000 platform

Study Type : Observational
Estimated Enrollment : 324 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: The Effect of Goal-directed Fluid Therapy on Postoperative Complications in Patients Undergoing Laparoscopic Hepatobiliary or Pancreatic Surgery
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery
U.S. FDA Resources

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.



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Laparoscopic hepatobiliary or pancreatic surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169998


Contacts
Contact: Hyo-Seok Na 1087012913 hsknana@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Contact: Hyo-Seok Na    1087012913    hsknana@gmail.com   
Sponsors and Collaborators
Seoul National University Bundang Hospital

Responsible Party: Hyo-Seok Na, Clinical professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03169998     History of Changes
Other Study ID Numbers: EV1000
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Liver Diseases
Postoperative Complications
Pancreatic Diseases
Digestive System Diseases
Pathologic Processes