Goal-Directed Therapy Following Cardiac Surgery

Not Applicable

Not yet recruiting

• Conditions: Surgery
• Interventions: Device: Goal-directed therapy

• Registration Number: NCT05964374
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-21
• Study Start: 2023-07
• Study First Submitted QC: 2023-07-19
• Last Update Submitted: 2023-07-19
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-01
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
24-hour cumulative IV fluid administration	24-hours	Cumulative post-operative intravenous fluid administration over the first 24-hours of index ICU admission.

Secondary Outcome Measures

Name	Time	Method
Length of Stay	Up to 1-year post-operative	Hospital length of stay
Study Protocol Compliance	1-year	Proportion of consented patients who complete all study assessments.
End-organ dysfunction/injury	Index admission, up to 30-days	Any surgical site infection
Arterial Monitoring Reliability	1-year	Number of arterial catheters requiring replacement
Vasoactive medication administration	Duration of ICU stay, up to 30-days	Duration
Enrollment	1-year	Proportion of eligible patients who consent to participate.
Transfusion	Index admission, up to 30-days	Total albumin administration
Mobilzation	Index admission, up to 30-days	Time to first mobilization (stand)
Mobilization	Index admission, up to 30-days	Time to first mobilization (walk)
Hydration	Index admission, up to 30-days	Time to first PO hydration
Fluid Administration	Duration of ICU stay, up to 30-days	Cumulative
Hemodynamic parameters	48-hours or when arterial line removed	Total Area Under the Curve (AUC) for MAP \< 65
Mortality	Up to 1-year post-operative	7-day, 30-day, and 1-year mortality.
GDT algorithm compliance	48-hours or when arterial line removed	Rationale for protocol suspensions
Nutrition	Index admission, up to 30-days	Time to first PO nutrition
Patient-centered Outcome	30-days	Canadian Patient Experiences Survey on Inpatient Care (CPES-IC) at 30-days
Re-admission	30-days	Incidence of hospital re-admission within 30-days of index surgery