RESIPI for Reducing Perioperative Major Adverse Cardiac Events

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-09

Study Completion Date

2018-12-03

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard intraoperative care- no interventions

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

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

No intervention

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).

Group Type EXPERIMENTAL

RESIPI Management Strategy

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

No intervention

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No