RESIPI for Reducing Perioperative Major Adverse Cardiac Events

N/ATerminatedNCT03208023

Vanderbilt University Medical Center155 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

155

Conditions

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

Interventions

RESIPI Management StrategyPROCEDURE

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).

No interventionOTHER

No intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

B-typer Natriuretic Peptide (BNP)

Change in BNP (\>250 ng/ml)

Time frame: Post Op day 1

Troponin

Change in troponin (\>=0.04%)

Time frame: Post Op day 1

Secondary Outcomes

All-cause mortality

Time frame: 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)

Time frame: 30 days post op

Hospital length of stay

Time frame: Approximately 3-5 days

Readmission rate (Emergency room or hospital)