RESIPI for Reducing Perioperative Major Adverse Cardiac Events (RESIPI)

RESIPI for Reducing Perioperative Major Adverse Cardiac Events: A Phase II Prospective Randomized Controlled Trial

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 Overview

• Status: Terminated
• Conditions: Hemodynamic Monitoring; Vascular Resistance; Cardiac Event; Fluid Responsiveness; Fluid Management; Inotropy; Perioperative Cardiac Risk; Hemodynamic Management
• Intervention / Treatment: Other: No intervention; Procedure: RESIPI Management Strategy

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 Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard intraoperative care- no interventions; Standard intraoperative hemodynamic monitoring and treatment at Vanderbilt University Medical Center - No study interventions	Other: No intervention; No intervention
Experimental: 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).	Procedure: 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, Inc).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
B-typer Natriuretic Peptide (BNP)	Change in BNP (>250 ng/ml)	Post Op day 1
Troponin	Change in troponin (>=0.04%)	Post Op day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		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)	30 days post op
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
Total hospital cost		30 days post operative
Occurrence of significant medical events	Occurrence of significant medical events (stroke, delirium, pneumonia, new oxygen requirement, need for re-intubation, acute kidney injury (KDIGO criteria), hyperglycemia (glucose >180)	30 days post operative
Days at home in first 30 days		30 days post operative

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Cheetah Medical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): December 3, 2018

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 170601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No