Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and non-Acute Coronary Syndrome related Cardiogenic Shock: a Multicenter Randomized Controlled Trial

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 250

Inclusion Criteria

- At least 18 years of age.
- Society for Cardiovascular Angiography and Interventions (SCAI) stage B or C
cardiogenic shock. For definitions, please see chapter 4 of the IABP ON-TIME
protocol (version 2.0).
- No more than 1 inotropic agent has been administered and the maximum dose of
noradrenaline/norepinephrine has not exceeded 0.2 µg/kg/min at the time of
randomization to reach mean arterial pressure >65 mmHg.

Exclusion Criteria

- Patient in cardiogenic shock, not fulfilling the definition for SCAI stage B
or C. For definitions, please see chapter 4 of the IABP ON-TIME protocol
(version 2.0).
- Administration of >=2 inotropic or vasopressive agents at the time of
randomization.
- Administration of noradrenaline/norepinephrine exceeding 0.2 µg/kg/min at the
time of randomization.
- Suspected or known mechanical complication contributing to cardiogenic shock,
e.g. ventricular septal defect or papillary muscle rupture.
- Cardiogenic shock developing within 72 hours of a surgical procedure (i.e.
low cardiac output with an inability to wean cardiopulmonary bypass).
- Inability to provide informed consent. Of note: patients admitted in
cardiogenic shock who required cardiopulmonary resuscitation earlier, but are
conscious at the time of hospital admission, are eligible for study
participation.
- Known or suspected insufficiency of the aortic valve with at least moderate
aortic regurgitation.
- Known or suspected peripheral arterial disease preventing safe insertion of
IABP.
- Known or suspected thoracic or abdominal aortic disease (including aortic
dissection or aortic aneurysm) precluding safe insertion and use of IABP.
- Suspicion of sepsis or septic shock (including septic cardiomyopathy).
- Pregnancy.
- Predicted life expectancy <6 months because of concomitant disease.
- Concurrent participation in a clinical trial with competing endpoints.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the trial is a composite of 1) all-cause mortality; 2)<br /><br>escalation to invasive mechanical ventilation; 3) escalation of MCS (including<br /><br>institution of IABP support in the standard of care-arm, or escalation to<br /><br>continuous flow or extracorporeal MCS); 4) acute kidney injury and 5) stroke or<br /><br>transient ischemic attack, at 30 days. </p><br>

Secondary Outcome Measures