Surgery
Conditions
Keywords
cardiac surgery, hemodynamic optimization, goal-directed therapy
Brief summary
Pilot prospective randomized control trial comparing goal-directed therapy algorithm vs routine care in the intensive care unit following cardiac surgery.
Detailed description
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.
Interventions
DEVICEGoal-directed therapy
Goal-directed therapy using HemoSphere® monitor, Acumen® transducer, and Hypotension Prediction Index® algorithm (Edwards Lifesciences, Irvine, USA),
Sponsors
University of Calgary
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years of age 2. Planned cardiac surgery using cardiopulmonary bypass (sternotomy or MICS) 3. Preoperative European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) of 2% or more. 4. Informed consent obtained.
Exclusion criteria
1. Emergency surgery 2. Patients who refuse participation 3. Patients who are unable to give informed consent 4. Patients who are having a heart or lung transplant. 5. Surgery for insertion of any ventricular assist device 6. Aortic arch procedures with any degree of debranching or hybrid with endovascular intervention in the ascending aorta +/- arch. 7. Patients who require MCS (including ECMO, Impella, or IABP) post-operatively 8. Patients on contact/droplet isolation. 9. Patients deemed excessively unstable and/or complex by their attending intensivist on arrival to the ICU. 10. If the post-operative arterial line MAP goal is not 65 mmHg. 11. Patients who suffer intra-operative mortality.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour cumulative IV fluid administration | 24-hours | Cumulative post-operative intravenous fluid administration over the first 24-hours of index ICU admission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluid Administration | Duration of ICU stay, up to 30-days | Daily average |
| Vasoactive medication administration | Duration of ICU stay, up to 30-days | Daily average |
| Hemodynamic parameters | 48-hours or when arterial line removed | Incidence of HPI \> 50 greater than 5-minutes |
| Enrollment | 1-year | Proportion of screened patients eligible for enrollment. |
| Study Protocol Compliance | 1-year | Proportion of consented patients who complete all study assessments. |
| Arterial Monitoring Reliability | 1-year | Number of arterial catheters requiring replacement |
| GDT algorithm compliance | 48-hours or when arterial line removed | Time from HPI \> 50 to application of an intervention |
| End-organ dysfunction/injury | Index admission, up to 30-days | Acute kidney injury |
| Transfusion | Index admission, up to 30-days | Total red-blood cell administration |
| Mobilzation | Index admission, up to 30-days | Time to first mobilization (dangle) |
| Mobilization | Index admission, up to 30-days | Time to first mobilization (walk) |
| Hydration | Index admission, up to 30-days | Time to first PO hydration |
| Nutrition | Index admission, up to 30-days | Time to first PO nutrition |
| Patient-centered Outcome | Index admission, up to 10-days | Quality of Recovery-15 (QOR-15) at post-op days 3, 5, 7, and 10. |
| Length of Stay | Up to 1-year post-operative | ICU length of stay |
| Re-admission | 30-days | Incidence of hospital re-admission within 30-days of index surgery |
| Mortality | Up to 1-year post-operative | 7-day, 30-day, and 1-year mortality. |
Countries
Canada
Outcome results
None listed