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
• Interventions: Other: No intervention; Procedure: RESIPI Management Strategy

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-05
• Study Start: 2017-10-09
• Primary Completion: 2018-11-01
• Study Completion: 2018-12-03
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-11
• Last Update Posted: 2022-11-17

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard intraoperative care- no interventions	No intervention	Standard intraoperative hemodynamic monitoring and treatment at Vanderbilt University Medical Center - No study interventions
RESIPI	RESIPI Management Strategy	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hospital length of stay	Approximately 3-5 days
Readmission rate (Emergency room or hospital)	30 days post operative
All-cause mortality	30 days post op
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)
Return to operating room	30 days post operative
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

Trial Locations

Locations (1)

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