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RESIPI for Reducing Perioperative Major Adverse Cardiac Events

Not Applicable
Terminated
Conditions
Cardiac Event
Inotropy
Fluid Responsiveness
Fluid Management
Vascular Resistance
Hemodynamic Monitoring
Hemodynamic Management
Perioperative Cardiac Risk
Registration Number
NCT03208023
Lead Sponsor
Vanderbilt University Medical Center
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
155
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
B-typer Natriuretic Peptide (BNP)Post Op day 1

Change in BNP (\>250 ng/ml)

TroponinPost Op day 1

Change in troponin (\>=0.04%)

Secondary Outcome Measures
NameTimeMethod
Hospital length of stayApproximately 3-5 days
Readmission rate (Emergency room or hospital)30 days post operative
All-cause mortality30 days post op
Major cardiac events30 days post op

Occurrence of major cardiac events (new arrhythmia, myocardial ischemia/infarction, congestive heart failure, or in-hospital cardiac arrest)

Total hospital cost30 days post operative
Occurrence of significant medical events30 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 days30 days post operative
Return to operating room30 days post operative

Trial Locations

Locations (1)

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States

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