RESIPI for Reducing Perioperative Major Adverse Cardiac Events

NCT03208023 — Not applicable, Terminated, 155 participants, Vanderbilt University Medical Center

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

Registry	NCT03208023, acronym RESIPI
Status	Terminated - Futility
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	155 (Actual)
Sponsor	Vanderbilt University Medical Center (Other); collaborators: Cheetah Medical Inc.
Conditions	Inotropy, Fluid Management, Cardiac Event, Perioperative Cardiac Risk, Vascular Resistance, Hemodynamic Monitoring, Hemodynamic Management, Fluid Responsiveness
Interventions	RESIPI Management Strategy, No intervention (Procedure, other)
Dates	start 2017-10-09, primary completion 2018-11-01, completion 2018-12-03, first posted 2017-07-05, last updated 2022-11-17
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Standard intraoperative care- no interventions	Active comparator	Other: No intervention	Standard intraoperative hemodynamic monitoring and treatment at Vanderbilt University Medical Center - No study interventions
RESIPI	Experimental	Procedure: 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).

RESIPI Management Strategy (Procedure): 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 intervention (Other): No intervention

+Outcome measures

Primary outcomes

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 outcomes

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)
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 [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]

+Eligibility

Sex: All, ages: 18 Years to any

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)

Facility	City	Country	Status
Vanderbilt University Medical Center	Nashville, Tennessee	United States

+Investigators

Matthew D McEvoy, M.D., Principal investigator, Vanderbilt University Medical Center

My Notes

Public

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