Goal Directed Fluid Therapy Clinical Trial
Official title:
Manual Versus Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery: A Randomized Controlled Trial
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05142163 -
Stroke Volume Variation and Plethysmography Variability Index as Goal Directed Fluid Therapy in Major Oncosurgeries
|
N/A | |
| Completed |
NCT00860704 -
Goal Directed Fluid Therapy
|
Phase 4 |