Pilot prospective randomized control trial comparing goal-directed therapy algorithm vs routine care in the intensive care unit following cardiac surgery.
Rationale: Goal-directed therapy (GDT) has been shown to reduce complications and length of stay on cardiac surgery patients. Unfortunately, the existing literature on GDT in CV surgery has several limitations, which creates uncertainty over the expected benefit of implementing this care element with high associated costs and impact on workflow. Hypotension Prediction Index (HPI) is a proprietary algorithm that utilizes pulse contour analysis from invasive arterial pressure monitoring to identify patients at risk for becoming hypotensive within 15 minutes. The algorithm was developed using machine learning on a large surgical/ICU data set, and then externally validated on non-cardiac and cardiac surgical patients. HPI, as part of a GDT algorithm, may allow healthcare providers to identify patients recovering from cardiac surgery who may benefit from optimization prior to becoming hypotensive and assist with selecting the most appropriate hemodynamic intervention. Hypothesis: Application of an HPI-based GDT algorithm will result in a difference in cumulative fluid administration over the first 24-hours of index ICU admission following cardiac surgery. Study Design: Unblinded randomized controlled trial pilot. Data will be used to inform/justify the feasibility, design, and implementation of a future multi-center randomized controlled trial. Study Population: Moderate or high-risk (EuroSCORE II \> 2%), non-emergent, adult open-heart cardiac surgery patients. Heart transplant, durable VAD implantation, or patients who require post-operative MCS support will be excluded. Sample size= 100 (50 control : 50 intervention) Intervention: Patients randomized to the intervention arm will be monitored using the HPI technology and be treated following a GDT algorithm when HPI is \>50 for 48-hours or duration of invasive arterial monitoring (whichever occurs first). The GDT algorithm is a standardized approach to identifying abnormal hemodynamic parameters and administering a prescribed therapy in a step-wise fashion with fixed re-assessment intervals (see attached). What will be different from routine care? : 1. Hemodynamic interventions (fluid, inotropic, or vasopressor therapy) will be administered when HPI \> 50 rather than MAP \< 65. 2. Choice of applied therapy (fluid, inotropic, or vasopressor therapy) will be guided by a GDT algorithm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Goal-directed therapy using HemoSphere® monitor, Acumen® transducer, and Hypotension Prediction Index® algorithm (Edwards Lifesciences, Irvine, USA),
Foothills Medical Centre
Calgary, Alberta, Canada
24-hour cumulative IV fluid administration
Cumulative post-operative intravenous fluid administration over the first 24-hours of index ICU admission.
Time frame: 24-hours
Fluid Administration
Daily average
Time frame: Duration of ICU stay, up to 30-days
Fluid Administration
Cumulative
Time frame: Duration of ICU stay, up to 30-days
Vasoactive medication administration
Daily average
Time frame: Duration of ICU stay, up to 30-days
Vasoactive medication administration
Daily cumulative
Time frame: Duration of ICU stay, up to 30-days
Vasoactive medication administration
Duration
Time frame: Duration of ICU stay, up to 30-days
Hemodynamic parameters
Incidence of HPI \> 50 greater than 5-minutes
Time frame: 48-hours or when arterial line removed
Hemodynamic parameters
Incidence of HPI \> 85 greater than 5-minutes
Time frame: 48-hours or when arterial line removed
Hemodynamic parameters
Incidence of MAP \< 65 greater than 5-minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 48-hours or when arterial line removed
Hemodynamic parameters
Total Area Under the Curve (AUC) for HPI \> 50
Time frame: 24-hours
Hemodynamic parameters
Total Area Under the Curve (AUC) for HPI \> 50
Time frame: 48-hours or when arterial line removed
Hemodynamic parameters
Total Area Under the Curve (AUC) for HPI \> 85
Time frame: 24-hours
Hemodynamic parameters
Total Area Under the Curve (AUC) for HPI \> 85
Time frame: 48-hours or when arterial line removed
Hemodynamic parameters
Total Area Under the Curve (AUC) for MAP \< 65
Time frame: 24-hours
Hemodynamic parameters
Total Area Under the Curve (AUC) for MAP \< 65
Time frame: 48-hours or when arterial line removed
Enrollment
Proportion of screened patients eligible for enrollment.
Time frame: 1-year
Enrollment
Proportion of eligible patients who consent to participate.
Time frame: 1-year
Study Protocol Compliance
Proportion of consented patients who complete all study assessments.
Time frame: 1-year
Arterial Monitoring Reliability
Number of arterial catheters requiring replacement
Time frame: 1-year
GDT algorithm compliance
Time from HPI \> 50 to application of an intervention
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
Proportion of hemodynamic interventions applied for HPI \> 50 that were recommended by the algorithm
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
Proportion of hemodynamic interventions applied for MAP \< 65 that would be recommended by the algorithm based on hemodynamic parameters.
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
MD notifications prompted by the GDT algorithm and resulting actions
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
Actions (therapies or investigations) prompted by an MD notification.
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
Number of study protocol suspensions
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
Duration of protocol suspensions
Time frame: 48-hours or when arterial line removed
GDT algorithm compliance
Rationale for protocol suspensions
Time frame: 48-hours or when arterial line removed
End-organ dysfunction/injury
Acute kidney injury
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Delirium
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Stroke
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Ileus
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Gut infarction
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Prolonged mechanical ventilation (\> 24 hours)
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Deep sternal wound infection
Time frame: Index admission, up to 30-days
End-organ dysfunction/injury
Any surgical site infection
Time frame: Index admission, up to 30-days
Transfusion
Total red-blood cell administration
Time frame: Index admission, up to 30-days
Transfusion
Total fresh-frozen plasma administration
Time frame: Index admission, up to 30-days
Transfusion
Total platelet administration
Time frame: Index admission, up to 30-days
Transfusion
Total albumin administration
Time frame: Index admission, up to 30-days
Mobilzation
Time to first mobilization (dangle)
Time frame: Index admission, up to 30-days
Mobilzation
Time to first mobilization (stand)
Time frame: Index admission, up to 30-days
Mobilization
Time to first mobilization (walk)
Time frame: Index admission, up to 30-days
Hydration
Time to first PO hydration
Time frame: Index admission, up to 30-days
Nutrition
Time to first PO nutrition
Time frame: Index admission, up to 30-days
Patient-centered Outcome
Quality of Recovery-15 (QOR-15) at post-op days 3, 5, 7, and 10.
Time frame: Index admission, up to 10-days
Patient-centered Outcome
World Health Organization Disability Assessment Schedule (WHODAS 2.0) at baseline, 2-weeks, 30-days, 90-days, and 1-year.
Time frame: Up to 1-year post-operative
Patient-centered Outcome
MacNew Questionnaire at baseline, 2-weeks, 30-days, 90-days, and 1-year.
Time frame: Up to 1-year post-operative
Patient-centered Outcome
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) at baseline, 2-weeks, 30-days, 90-days, and 1-year.
Time frame: Up to 1-year post-operative
Patient-centered Outcome
Canadian Patient Experiences Survey on Inpatient Care (CPES-IC) at 30-days
Time frame: 30-days
Length of Stay
ICU length of stay
Time frame: Up to 1-year post-operative
Length of Stay
Hospital length of stay
Time frame: Up to 1-year post-operative
Re-admission
Incidence of hospital re-admission within 30-days of index surgery
Time frame: 30-days
Mortality
7-day, 30-day, and 1-year mortality.
Time frame: Up to 1-year post-operative