Individualized Fluid And Vasopressor Administration In Surgical Patients
Condition: Intraoperative Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to compare two different strategies of intraoperative mean
      arterial pressure (MAP) and stroke volume index management in high-risk patients undergoing
      major abdominal and orthopedic surgery (manual versus automated) The investigators hypothesis
      is that the automated group will spend less time during surgery in hypotension (defined as a
      MAP<90% of patient's MAP baseline) compared to the manual group.
    

Detailed description: 
      The maintenance of MAP is essential for organ perfusion pressure. Intraoperative hypotension
      is a frequent complication both after induction and during maintenance of anaesthesia,
      ranging from 5% to 75% depending on the chosen definition. Tissue hypoperfusion exposes to
      the occurrence of a systemic inflammatory response syndrome and is a key determinant of
      postoperative complications. Persistent intraoperative hypotension has been reported as an
      important prognostic factor of postoperative morbidity and mortality. Adequate treatment of
      arterial hypotension is therefore of particular importance during surgery. However, the
      avoidance of hypotension includes the infusion of vasopressor and/or fluid to optimize
      perfusion pressure. The manual adjustment of vasopressor administration has been shown to be
      suboptimal.

      Recently, a paper published in the JAMA journal demonstrated that among patients undergoing
      high-risk surgery, the maintenance of blood pressure within 10% of patient's baseline
      systolic blood pressure resulted in less postoperative organ dysfunction compared to standard
      MAP management.

      Today, the investigators have an automated clinical decision support system that help ease
      the administration of both fluid and vasopressors during surgery (individualized fluid and
      vasopressor administration). The department of the investigators has recently implemented a
      manual hemodynamic protocol to optimize fluid and vasopressor. The goal is to maintain stroke
      volume index within 90% of the optimal stroke volume via mini fluid challenge of crystalloid
      solution (100 ml) following the French guidelines and to maintain MAP within 90 % of
      patient's baseline MAP. This protocol has been called : Individualized Fluid and vasopressor
      protocol (because based on patient's values) The purpose of this study is therefore to
      compare two different strategies of intraoperative mean arterial pressure (MAP) and stroke
      volume index management in high-risk surgical patients (manual versus automated and decision
      support guided) The investigators hypothesis is that automated group will spend less time
      during surgery in hypotension (defined as a MAP<90% of patient's MAP baseline) compared to
      the manual group because patient's stroke volume and MAP will be better maintained during
      surgery (within 10% of patient' targets).The decision support system will remind the
      clinician when to administer a bolus of fluid to maintain stroke volume index within 10% of
      the optimize stroke volume index value and an automated closed-lopp system will titrate
      norepinephrine to keep MAP within 10% of patient's MAP target. The study will thus compare an
      individualized hemodynamic protocol (already in place in our institution) applied manually to
      a decision support-and closed-loop guided- individualized hemodynamic protocol (intervention
      group).
    

Intervention name(s): Automated management of hypotension
Intervention type(s): Device
Intervention description(s): Fluid and vasopressor will be administered based on a novel automated clinical decision support system.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment