ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery

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

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-02-29

Brief Summary

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The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30 days compared with standard care alone, while maintaining acceptable safety with respect to vascular accesss-related complications.

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Detailed Description

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Conditions

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Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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No IABP

Standard of care and no IABP

Group Type NO_INTERVENTION

No interventions assigned to this group

Intra-Aortic Balloon Pump (IABP)

Standard of care, IABP inserted \< or = 3 hours before noncardiac surgery, maintained for \> or = 12-24 hours after surgery

Group Type ACTIVE_COMPARATOR

IABP

Intervention Type DEVICE

Insertion of intra-aortic balloon \< or = 3 hours before noncardiac surgery and maintained \> or = 12-24 hours after surgery

Interventions

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IABP

Insertion of intra-aortic balloon \< or = 3 hours before noncardiac surgery and maintained \> or = 12-24 hours after surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients \> 18 years with planned elective major abdominal, noncardiac thoracic, head and neck, vascular, or orthopedic surgery and guideline-treated iscehmic heart disease with left ventricular dysfunction (systolic ejection fraction \< or = 30%)

Exclusion Criteria

* Unstable coronary syndromes Decompensated or NYHA Class IV heart failure Hemodynamic instability Cardiac biomarker instability Need for surgical procedure interfering with placement of IABP Cardiogenic shock Septic shock Contraindication to IABP use Clinical need for IABP ASA score \> or = 5 Pregnancy Inability to provide informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No