Effect of Goal-directed Fluid Therapy on Postoperative Complications
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03169998|
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
- 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|
|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|
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).
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.
- Pulmonary complication [ Time Frame: Postoperative 90 day ]
- Wound complication [ Time Frame: Postoperative 90 day ]
- Acute kidney injury [ Time Frame: Postoperative 90 day ]
- Delirium [ Time Frame: Postoperative 90 day ]
- Deep vein thrombosis [ Time Frame: Postoperative 90 day ]
- Myocardiac infarction [ Time Frame: Postoperative 90 day ]
- Stroke [ Time Frame: Postoperative 90 day ]
- Sepsis [ Time Frame: Postoperative 90 day ]
- Urinary tract infection [ Time Frame: Postoperative 90 day ]
- Death [ Time Frame: Postoperative 90 day ]
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
|Contact: Hyo-Seok Naemail@example.com|
|Korea, Republic of|
|Seoul National University Bundang Hospital||Recruiting|
|Seongnam, Gyeonggi, Korea, Republic of, 463-707|
|Contact: Hyo-Seok Na 1087012913 firstname.lastname@example.org|