ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery

Datascope

Status and phase: Terminated; Phase 4

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

Treatments: Device: IABP

Study type: Interventional

Funder types: Industry

Identifiers

NCT01253356

P-00002

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

No IABP

No Intervention group

Description:

Standard of care and no IABP

Intra-Aortic Balloon Pump (IABP)

Active Comparator group

Description:

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

Treatment:

Device: IABP