ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery

Phase 4TerminatedNCT01253356

Datascope Corp.1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

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

Interventions

IABPDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Genesis Medical Center

Davenport, Iowa, United States

Outcomes

Primary Outcomes

Safety

Amputation, Clinically significant bleeding, Vascular complications

Time frame: 30 days

Secondary Outcomes

Efficacy

A composite of the following: All-cause mortality, Cardiovascular mortality, Hemorrhagic or ischemic stroke, New nonfatal myocardial infarction, New or worsening congestive heart failure, Hemodynamically significant arrhythmia requiring intervention

Time frame: 30 days

Data from ClinicalTrials.gov

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