Goal-Directed Therapy Following Cardiac Surgery

University of Calgary

Status: Not yet enrolling

Conditions: Surgery

Treatments: Device: Goal-directed therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05964374

REB23-0043

Details and patient eligibility

About

Pilot prospective randomized control trial comparing goal-directed therapy algorithm vs routine care in the intensive care unit following cardiac surgery.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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. Patients who refuse participation
2. Patients who are unable to give informed consent
3. Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
4. Emergency surgery
5. Patients who require MCS (including ECMO, Impella, or IABP) post-operatively

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Control

No Intervention group

Description:

Routine post-operative clinical care.

Intervention

Experimental group

Description:

Goal-directed therapy algorithm in addition to routine post-operative clinical care.

Treatment:

Device: Goal-directed therapy