Control Mean Arterial Pressure in the Intensive Care Unit
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The goal of this randomized controlled trial is to compare two different strategies of
      postoperative mean arterial pressure (MAP) management (manual versus automated) in patients
      who underwent a major surgery and admitted in the intensive care unit or post-anesthesia care
      unit for postoperative care. The investigators hypothesis is that the automated group will
      spend more time in a predetermined target MAP range of 80-90 mmHg compared to the manual
      group.
    

Detailed description: 
      Although the correction of hypotension during the perioperative period should be a key goal,
      approximately 40% of overall mortality is still closely linked to the presence of
      perioperative hypotension which is responsible for significant morbidity particularly in
      patients undergoing major surgery. Indeed, inadequate management of perioperative hypotension
      remains an undeniable risk factor for morbidity and mortality. However, management of
      perioperative mean arterial pressure (MAP) is still suboptimal today. Indeed, the analysis of
      our database demonstrates that, on average, patient spends only 50-60 % of the treatment time
      within the predetermined MAP target. In about 10% of the treatment time, the patient is
      under-treated (hypotension) and 30% of the time, the patient is over-treated (hypertension).

      The correction of hypotension is achieved using vasopressor drugs (mainly norepinephrine
      infusion). In 2017 a study published in the JAMA shows that patients with tightly controlled
      arterial pressure have fewer organ dysfunctions than those with standard blood pressure
      management. However, maintaining MAP within a narrow range involves regular manual
      adjustments of norepinephrine infusion doses by intensive care unit nurses. When a
      hypotension occurs, there is usually two main possible treatments (fluid or vasopressors). In
      the operating room, for patients undergoing major surgery, we usually optimize fluid and
      vasopressor titration using an advanced hemodynamic monitoring device "EV1000 monitor"
      (Edwards Lifesciences, Irvine USA).This monitoring device can also be connected to a computer
      that controls a norepinephrine infusion pump in order to tightly adjust the infusion of
      norepinephrine to the target MAP predetermined by the clinician in charge of the patients. We
      have recently demonstrated that the use of such system resulted in less intraoperative time
      in hypotension compared to manual management. However, in the postoperative period, in
      patients admitted in the intensive care unit after a major surgery and requiring tight
      control of MAP, such demonstration is still lacking.

      Therefore, the objective of this randomized controlled superiority study is to demonstrate
      that, in patients admitted to intensive care unit or post-anesthesia care unit after a major
      surgery, tight control of MAP using a closed-loop system for vasopressor administration will
      result in MAP being more often within a predetermined MAP range of 80-90 mmHg compared to the
      same management without this automated closed-loop system (nurse adjustment of vasopressor
      administration).
    

Intervention name(s): Automated adjustment of vasopressor; Manual adjustment of vasopressor
Intervention type(s): Device; Device
Intervention description(s): The objective of this randomized controlled superiority study is to demonstrate that, in patients admitted to intensive care after a major surgery, tight control of MAP using a closed-loop system for vasopressor administration will result in MAP being more often within a MAP range of 80-90 mmHg compared to the same management without this automated closed-loop system (nurse adjustment of vasopressor administration); Fluid and vasopressor will be delivered as standard of care (manual adjustment of both fluid and vasopressor infusion rate by the nurse)
Intervention MeSH terms: Vasoconstrictor Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Active comparator (manual adjustment of vasopressor infusion) and Experimental (automated management of vasopressor infusion)
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Intraoperative hypotension; intensive care unit; hemodynamic management