RESIPI for Reducing Perioperative Major Adverse Cardiac Events

Study Overview
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Brief Summary
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This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.

Detailed Description
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Modest elevations in cardiac biomarkers in the immediate postoperative period are associated with significantly increased risk of morbidity and mortality. The RESIPI model of hemodynamic monitoring and management in the perioperative period takes into account the dynamic interplay of vascular resistance, inotropy, and fluid management. This study aims to evaluate the effect of a novel hemodynamic management and monitoring strategy for reducing cardiac bio marker elevations and major adverse cardiac events.

Official Title
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RESIPI for Reducing Perioperative Major Adverse Cardiac Events: A Phase II Prospective Randomized Controlled Trial

Conditions
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Inotropy, Fluid Management, Cardiac Event, Perioperative Cardiac Risk, Vascular Resistance, Hemodynamic Monitoring, Hemodynamic Management, Fluid Responsiveness

Intervention / Treatment
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* Procedure: RESIPI Management Strategy
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Revised Cardiac Risk Index greater than or equal to 1, history of diastolic dysfunction, or age greater than 55 years. Surgery type: Major Abdominal Oncologic Surgery Planned surgery length greater than or equal to 90 minutes with planned in-patient stay of at least 2 days Exclusion Criteria: Patients who are unstable by current American Heart Association/American College of Cardiology Clinical Practice Guidelines Patients with Chronic Kidney Disease Stage IV or V Urgent/emergent surgical interventions (e.g. Level 1 or 2 by VUMC VOR definitions) No signs of ischemia, congestive heart failure, or volume overload: Creatinine Clearance greater than 30

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard intraoperative care- no interventions<br>Standard intraoperative hemodynamic monitoring and treatment at Vanderbilt University Medical Center - No study interventions | Other: No intervention<br>* No intervention<br>|
| Experimental: RESIPI<br>Intraoperative implementation of RESIPI management strategy, a structured hemodynamic monitoring and treatment plan: RESIPI includes normalization of vascular resistance, correction of fluid responsiveness, and inotropy, and hemodynamic monitoring with the Starling SV (Cheetah Medical). | Procedure: RESIPI Management Strategy<br>* a structured hemodynamic monitoring and treatment plan: RESIPI includes normalization of vascular resistance, correction of fluid responsiveness, and inotropy, and hemodynamic monitoring with the Starling SV (Cheetah Medical, Inc).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| B-typer Natriuretic Peptide (BNP) | Change in BNP (>250 ng/ml) | Post Op day 1 | 
| Troponin | Change in troponin (>=0.04%) | Post Op day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 30 days post op | 
| Major cardiac events | Occurrence of major cardiac events (new arrhythmia, myocardial ischemia/infarction, congestive heart failure, or in-hospital cardiac arrest) | 30 days post op | 
| Hospital length of stay |  | Approximately 3-5 days | 
| Readmission rate (Emergency room or hospital) |  | 30 days post operative | 
| Return to operating room |  | 30 days post operative | 
| Total hospital cost |  | 30 days post operative | 
| Occurrence of significant medical events | Occurrence of significant medical events (stroke, delirium, pneumonia, new oxygen requirement, need for re-intubation, acute kidney injury (KDIGO criteria), hyperglycemia (glucose >180) | 30 days post operative | 
| Days at home in first 30 days |  | 30 days post operative |