An interventional study of Use of a decision support system on the EV1000 monitor (AFM mode) in Goal Directed Fluid Therapy, sponsored by Erasme University Hospital. Withdrawn at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-05-14.
Sponsored by Erasme University Hospital · Not applicable, Interventional, and Treatment
This study will compare a group of patients managed with a manual GDFT protocol (using the EV1000 monitoring device; Edwards Lifesciences, Irvine, USA) to a group of patients managed using a decision support system for GDFT guidance (implemented on the same EV1000 monitoring) in patients undergoing major abdominal and orthopedic surgery.
Many trials have indicated that goal-directed fluid therapy (GDFT) strategies may benefit high-risk surgical patients but these strategies are infrequently implemented. It has also been shown that without any goal or protocol for fluid resuscitation, large inter- and intra-provider variability exist and have been correlated with marked variations in patient outcomes. Even under ideal study conditions, strict adherence to GDFT protocols is hampered by the workload and concentration required for consistent implementation.Haemodynamic monitors and protocols alone do not enable optimal fluid titration to be provided consistently to all patients - there must also be appropriate and timely interpretation and intervention.
To address this problem of consistency and protocol adherence, a clinical decision support system, "Assisted Fluid Management" (AFM), has been designed to help ease some of the workload associated with GDFT protocol implementation. The AFM system (released on the European market in March 2017) may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers. This system can suggest fluid bolus administration, analyse the effects of the bolus, and continually re-assess the patient for further fluid requirements.
A recent published study demonstrated that the implementation of the AFM for GDFT guidance resulted in a significantly longer period during surgery with a SVV \<13% with a reduced total amount of fluid administered without any difference in postoperative complications. Therefore the goal of this randomized controlled trial is to compare a manual GDFT approach ( standard of care actually in the department) versus an Assisted fluid management approach (using the AFM mode) on the incidence of minor postoperative complications.
Erasme University Hospital is the lead sponsor of 178 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group of patients will receive fluid administration during surgery based on a manual GDFT protocol actually in place in the department using the EV1000 monitoring device (Edwards Lifesciences, Irvine, USA)
Other: Use of a decision support system on the EV1000 monitor (AFM mode)
This group of patients will receive fluid administration during surgery based on a novel clinical decision support system for GDFT guidance using the EV1000 monitoring device (Edwards Lifesciences, Irvine, USA)
Other: Use of a decision support system on the EV1000 monitor (AFM mode)
The way to administer fluid is based on the same monitoring device but will differ by the way fluid is given ( following a manual GDFT protocol versus following recommendation from an active clinical deicsion support system for fluid administration called AFM (assisted fluid management)
composite criteria of minor postoperative complications
This composite score includes 8 items : 1. postoperative nausea and vomiting 2. delirium and confusion 3. Infection of surgical site 4. urinary infection 5. acute kidney injury (KDIGO I \& II classiciation) 6. paralytic ileus 7. other infection (skin, catheter, unknown etc) 8. Readmission to the hospital within 30 days postoperative
Time frame: 30 days postsurgery
Percentage of Time spent during the procedure with a stroke volume variation < 13%
Percentage of Time spent during the procedure with a stroke volume variation \< 13%
Time frame: Postoperative day 1
Percentage of Time spent during the procedure with a Cardiac index >2.5l/min/m2
Percentage of Time spent during the procedure with a Cardiac index \>2.5l/min/m2
Time frame: Postoperative day 1
composite criteria of major postoperative complications
This composite score includes 14 items : 1. stoma dehiscence 2. Peritonitis 3. Sepsis 4. wound dehiscence 5. bleeding requiring a redo surgery 6. pulmonary embolism 7. pulmonary edema 8. Pneumonia 9. acute coronary syndrome 10. atrial fibrillation 11. stroke 12. Dialysis 13. non scheduled redo surgery 14. 30days mortality (all causes)
Time frame: 30 days postsurgery
cardiac index over the procedure
average cardiac index over the surgery
Time frame: Postoperative day 1
stroke volume over the procedure
average stroke volume over the procedure
Time frame: Postoperative day 1
stroke volume variation over the procedure
average stroke volume variation over the procedure
Time frame: Postoperative day 1
Total Fluid received during the procedure
amount of fluid received during surgery
Time frame: Postoperative day 1
Net fluid balance
Net fluid balance at the end of the ICU stay
Time frame: Postoperative day 1
Postoperative acute care unit or intensive care unit length of stay
Postoperative acute care unit or intensive care unit length of stay
Time frame: 30 days postsurgery
Hospital length of stay
hospital length of stay
Time frame: 30 days postsurgery
Plan to share: No
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This study is withdrawn, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Erasme University Hospital