Impact of an Assisted Fluid Management System on Microvascular Parameters
Condition: Monitoring
Study type: Interventional

Summary: 
      This study will compare a group of patients managed with a manual GDFT protocol (using the
      EV1000 monitoring device; Edwards Life sciences, Irvine, USA) to a group of patients managed
      using a novel real time clinical decision support system for goal directed fluid therapy
      (GDFT) guidance on microvascular parameters in patients undergoing major abdominal or
      orthopedic surgery.
    

Detailed description: 
      Many trials have indicated that GDFT strategies may benefit high-risk surgical patients but
      these strategies are infrequently implemented on a day to day basis. 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 novel real time 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.

      Mean arterial pressure will be at least maintained in both groups above 65 mmHg with
      norepinephrine administration. Vasopressors administration is standardised in both groups
      (objective is a MAP of > 65 mmHg) and the only difference will be the way fluid boluses are
      given to the patient (following standard of care (manual protocol) of following the assisted
      fluid management recommandations)

      A recent published study demonstrated that the implementation of the AFM for GDFT guidance
      resulted in a significantly longer period during surgery in a preload independent state
      (defined as a SVV < 13%) with a reduced total amount of fluid administered without any
      difference in postoperative complications.

      Another recent study demonstrated that during abdominal surgery, microvascular perfusion is
      impaired during preload dependence (SVV >13%) and recovers after fluid administration
      (preload independent state)

      Therefore the goal of this bicentric 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 Microvascular flow index.

      We assume that this novel clinical decision support system will allow patients to have less
      alterations of their microvascular parameters than patients managed under standard of care
      (GDFT but without the assisted fluid management mode)
    

Intervention name(s): Use of a decision support system on the EV1000 monitoring (AFM mode); Manual application of the GDFT protocol (standard of care)
Intervention type(s): Device; Other
Intervention description(s): 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 decision support system for fluid administration called AFM (assisted fluid management) Measurement of all microvascumlar parameters in blinded way. Blood pressure wil standardized in both group.; Manual application of a GDFT protocol to guide fluid administration. Measurement of all microvascumlar parameters in blinded way. Blood pressure wil standardized in both group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other