(non-) ischemic cardiogenic shock Heart failure
Conditions
Interventions
Patients enrolled in this trial will be 1:1 randomized to IABP support or
standard of care (i.e. inotropes and/or vasopressors but no IABP insertion).
Patients will be stratified for ACS/non-ischemi
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the trial is a composite of 1) all-cause mortality; 2) escalation to invasive mechanical ventilation; 3) escalation of MCS (including institution of IABP support in the standard of care-arm, or escalation to continuous flow or extracorporeal MCS); 4) acute kidney injury and 5) stroke or transient ischemic attack, at 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include at 1 year 1) all-cause mortality and 2) unplanned hospital re-admission for cardiovascular causes. The following secondary trial endpoints will also be investigated throughout the trial (at 30-day follow-up, if not specified otherwise): - The individual determinants of the composite primary outcome. - Treatment escalation (see chapter 8 of the IABP ON-TIME protocol, version 2.0). - Deterioration of cardiogenic shock. - Vascular complications following randomization to the IABP-arm. - Major bleeding complications following randomization to the IABP-arm. - De novo Acute Coronary Syndrome (ACS) (i.e. type 1 Myocardial Infarction) both at 30-days and 1-year follow-up. - Cardiopulmonary resuscitation or defibrillation. - The development of Systemic Inflammatory Response Syndrome (SIRS), sepsis or severe sepsis within 96 hours after randomization. | — |
Countries
Netherlands
Outcome results
None listed