Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II)

University of Leipzig

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction; Shock, Cardiogenic

Treatments: Device: Intraaortic balloon pump

Study type: Interventional

Funder types: Other

Identifiers

NCT00491036

342

Details and patient eligibility

About

Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion criteria computerized randomization is performed to either PCI plus intraaortic balloon pump (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care treatment is performed according to standard care including hemodynamic monitoring using a pulmonary artery catheter for optimal volume status adaptation and inotropic drug administration.

The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be 30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and clinical parameters will serve as surrogate for prognosis of the patients.

Enrollment: 600 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Cardiogenic shock complicating acute myocardial (STEMI or NSTEMI) with

• intended revascularization (PCI or CABG)

• Systolic blood pressure < 90 mmHg > 30 min or inotropes required to maintain pressure > 90 mmHg during systole

• Signs of pulmonary congestion

• Signs of impaired organ perfusion with at least one of the following:

  • Altered mental status
  • Cold, clammy skin
  • Urine output <30 ml/h
  • Serum lactate >2mmol/l

• Informed consent

Exclusion criteria

• Resuscitation > 30 minutes
• Cerebral deficit with fixed dilated pupils
• No intrinsic heart action
• Mechanical infarction complication
• Onset of shock > 12 h
• Severe peripheral artery disease
• Aortic regurgitation > II.°
• Age > 90 years
• shock of other cause
• Other severe concomitant disease
• participation in another trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Intraaortic balloon pump

Active Comparator group

Description:

Patients in cardiogenic shock get an intraaortic balloon pump in the cath lab

Treatment:

Device: Intraaortic balloon pump

No intraaortic balloon pump

No Intervention group

Description:

Patients in cardiogenic shock in this group get no intraaortic balloon pump