Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964374
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-06-21
Brief Title:
Goal-Directed Therapy Following Cardiac Surgery
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Goal-Directed Therapy GDT Using Hypotension Prediction Index HPI Following Cardiac Surgery a Pilot Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 surgicalICU 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 informjustify 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
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 surgicalICU 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 informjustify 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None