Cardiac Event, Fluid Management, Fluid Responsiveness, Hemodynamic Management, Hemodynamic Monitoring, Inotropy, Perioperative Cardiac Risk, Vascular Resistance
Conditions
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.
Interventions
PROCEDURERESIPI 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, Inc).
OTHERNo intervention
No intervention
Sponsors
Cheetah Medical Inc.
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| B-typer Natriuretic Peptide (BNP) | Post Op day 1 | Change in BNP (\>250 ng/ml) |
| Troponin | Post Op day 1 | Change in troponin (\>=0.04%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| All-cause mortality | 30 days post op | — |
| Occurrence of significant medical events | 30 days post operative | Occurrence of significant medical events (stroke, delirium, pneumonia, new oxygen requirement, need for re-intubation, acute kidney injury (KDIGO criteria), hyperglycemia (glucose \>180) |
| Days at home in first 30 days | 30 days post operative | — |
| Total hospital cost | 30 days post operative | — |
| Major cardiac events | 30 days post op | Occurrence of major cardiac events (new arrhythmia, myocardial ischemia/infarction, congestive heart failure, or in-hospital cardiac arrest) |
Countries
United States
Outcome results
None listed