RESIPI for Reducing Perioperative Major Adverse Cardiac Events

Vanderbilt University Medical Center

Status: Terminated

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

Treatments: Other: No intervention; Procedure: RESIPI Management Strategy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03208023

170601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

155 participants in 2 patient groups

Standard intraoperative care- no interventions

Active Comparator group

Description:

Standard intraoperative hemodynamic monitoring and treatment at Vanderbilt University Medical Center - No study interventions

Treatment:

Other: No intervention

RESIPI

Experimental group

Description:

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).

Treatment:

Procedure: RESIPI Management Strategy