Abdominal Laparoscopic and/or Robotic Surgery Clinical Trial
Official title:
Automated Closed-Loop Versus Restrictive Fluid Therapy in Abdominal Surgery: a Pilot Randomized Controlled Trial
The aim of this study is to compare hemodynamic variables and outcome in patients undergoing laparoscopic and/or robotic elective abdominal surgery. Patients will receive either an automated closed-loop goal-directed fluid therapy (GDFT) guided by non-invasive flow monitoring or a restrictive fluid therapy of 4ml/kg/h.
Perioperative fluid management is a topic of much debate that has intensified over recent
years. Studies have shown improved postoperative outcomes with restricted fluid
administration in the perioperative period for moderate risk abdominal surgery. They
concluded that in patients undergoing elective abdominal surgery, intraoperative restrictive
fluid management was associated with a reduction in postoperative morbidity and shortened
hospital stay. Current standard practice is a crystalloid based fluid therapy guided by
static hemodynamic parameters such as heart rate, blood pressure, and diuresis. However,
several studies have criticized this cookbook approach and recommend tailoring management to
specific physiologic dynamic endpoints such as stroke volume variation and cardiac output
using a flow monitoring device. Our team has demonstrated that the use of a closed-loop
system is feasible and allows precise titration of fluid administration in abdominal and
vascular surgery using either a minimally or a non-invasive monitoring system.
Goal:
This study compares hemodynamic variables and outcome in patients who will receive either
automated closed-loop fluid therapy guided by non-invasive flow monitoring or restrictive
fluid therapy of 4ml/kg/h. Both groups consist of the same population undergoing
laparoscopic and/or robotic surgery.
Hypothesis:
A closed-loop assisted intraoperative GDFT when compared to restrictive fluid therapy will
provide better hemodynamic variables.
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