RESIPI for Reducing Perioperative Major Adverse Cardiac Events: A Phase II Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 155
- Locations
- 1
- Primary Endpoint
- Troponin
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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).
Intervention: RESIPI Management Strategy (Procedure)
Standard intraoperative care- no interventions
Standard intraoperative hemodynamic monitoring and treatment at Vanderbilt University Medical Center - No study interventions
Intervention: No intervention (Other)
Outcomes
Primary Outcomes
Troponin
Time Frame: Post Op day 1
Change in troponin (\>=0.04%)
B-typer Natriuretic Peptide (BNP)
Time Frame: Post Op day 1
Change in BNP (\>250 ng/ml)
Secondary Outcomes
- Days at home in first 30 days(30 days post operative)
- Hospital length of stay(Approximately 3-5 days)
- Readmission rate (Emergency room or hospital)(30 days post operative)
- All-cause mortality(30 days post op)
- Major cardiac events(30 days post op)
- Total hospital cost(30 days post operative)
- Return to operating room(30 days post operative)
- Occurrence of significant medical events(30 days post operative)
Investigators
Matthew McEvoy
Professor
Vanderbilt University Medical Center