RESIPI for Reducing Perioperative Major Adverse Cardiac Events
Purpose
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.
Conditions
- Inotropy
- Fluid Management
- Cardiac Event
- Perioperative Cardiac Risk
- Vascular Resistance
- Hemodynamic Monitoring
- Hemodynamic Management
- Fluid Responsiveness
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Standard intraoperative care- no interventions |
Standard intraoperative hemodynamic monitoring and treatment at Vanderbilt University Medical Center - No study interventions |
|
|
Experimental RESIPI |
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). |
|
More Details
- Status
- Terminated
- Sponsor
- Vanderbilt University Medical Center
Study Contact
Detailed Description
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.