An interventional study of the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device in Goal-directed Fluid Therapy, sponsored by Beijing Tongren Hospital. Completed at 1 site in China. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-03-09.
Sponsored by Beijing Tongren Hospital · Not applicable, Interventional, and Treatment
The investigators conduct this randomized assessor-blinded controlled trial to evaluate the effect of SVV-guided fluid therapy on postoperative morbidity and mortality in comparison with conventional fluid therapy after major abdominal surgery. Half of participants will receive GDFT perioperatively, and the others will receive conventional fluid therapy
Perioperative fluid management has been recognized as an important factor with an impact on postoperative recovery following major abdominal surgery. However, the optimal fluid management is difficult to achieve using standard parameters (e.g., heart rate [HR], blood pressure [BP], central venous pressure[CVP], or urine output) that poorly estimate preload and preload responsiveness. Goal-directed fluid therapy (GDFT) was proposed by introducing different hemodynamic variables into a dynamic perspective of individual fluid loading with or without vasoactive substances to reach predefined goal of optimal preload and/or oxygen delivery.There have been increasing numbers of studies evaluating the effect of perioperative GDFT on postoperative recovery following major abdominal surgery. However, the evidence for the beneficial effect of GDFT on postoperative recovery remains inconsistent.
Beijing Tongren Hospital is the lead sponsor of 154 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Stroke Volume variation (SVV)-guided fluid therapy
Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device
Conventional fluid therapy such as CVP and MAP guided fluid therapy
Device: the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device
Stroke volume variation (SVV)-guided fluid therapy
Length of hospital stay
from the end of surgery to discharge from hospital
Time frame: from the end of surgery to discharge from hospital up to 30 days after surgery
GI function
number of participants with I-FEED score \>6
Time frame: from the end of surgery to 30 days after surgery
mortality
death after surgery
Time frame: from the end of surgery to 1 year after surgery
postoperative pain score
VAS for pain :0 no pain and 10 for worst pain
Time frame: 1 day, 3 days and 5 days after surgery
postoperative recovery quality
QoR-15 :quality of recovery score : 0 worst recovery quality and 150 for best recovery
Time frame: 1 day, 3 days and 5 days after surgery
Postoperative complications
number of any complications after surgery
Time frame: from end of surgery to 30 days after surgery
Plan to share: No
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Beijing Tongren Hospital