Cardiogenic Shock Intravascular Cooling Trial

This is an unblinded pilot study of 20 patients randomized to either TH plus standard medical
care or to standard medical care alone. All patients will undergo pulmonary artery (PA)
catheter placement as part of the standard of care for management of cardiogenic shock. Data
from the PA catheter is vital in monitoring real-time hemodynamics, initiating
vasopressors/inotropes, assessing the response to the therapies, and possible need for
escalation of therapy.

For patients randomized to TH, cooling to 32-34°C will then be initiated and maintained for
24 hours using the FDA-approved Intravascular Temperature Management (IVTM™) System with the
9.3 French Quattro® Catheter. The IVTM™ System along with the Quattro® Catheter are currently
FDA-approved for use in cardiac surgery patients to achieve and maintain normothermia during
surgery and in recovery and to induce, maintain, and reverse mild hypothermia in neurosurgery
patients during surgery and in recovery. The IVTM™ System and Quattro® Catheter are not,
however, currently FDA-approved to achieve therapeutic hypothermia in cardiogenic shock
patients. TH is achieved by circulating normal saline in a closed system through the
catheter. The temperature is measured and adjustments are made by the thermal regulation
system to automatically maintain target temperature. The target temperature is achieved
within 2-3 hours of initiation of TH. Rewarming is accomplished using the same balloon
catheter system and heat exchange occurs without infusion of any saline or fluids.

Standard medical therapy for all patients will be based on the current recommendations for
management of cardiogenic shock. This includes inotropic therapy for cardiac support,
vasopressor therapy to achieve target blood pressure, diuretics for volume removal, and
mechanical circulatory support as clinically indicated. Laboratory, echocardiographic, and
hemodynamic parameters will be obtained for patients prior to randomization, after 18-24
hours post-randomization, and after 48-96 hours post-randomization. Core temperature will be
measured via either thermal tip at the end of a transurethral urinary catheter or
endotracheal temperature probe in intubated patients.

Inclusion Criteria:

1. Cardiogenic shock

1. Systolic blood pressure <90mmHg for at least 30 minutes

2. Cardiac Index < 2.2 L/min/m2

3. Pulmonary capillary wedge pressure (PCWP) ≥ 15mmHg

4. Need for central venous access, vasopressors, inotropes and/or mechanical
circulatory support (i.e. intra-aortic balloon pump, Impella®, ECMO) to maintain
systolic blood pressure ≥ 90mmHg

2. Etiology of shock

1. Acute coronary syndromes (STEMI, NSTEMI, or UA)

2. Ischemic or non-ischemic cardiomyopathy

3. Myocarditis

4. Hypertrophic cardiomyopathy

5. Stress-induced cardiomyopathy

6. Peripartum cardiomyopathy

7. Cardiogenic shock in a patient with heart failure with preserved ejection
fraction

3. Age ≥ 18 years AND ≤ 89 years

4. Admission to the University of Chicago Coronary Care Unit

Exclusion Criteria:

1. Baseline heart rate < 60 beats per minute

2. Baseline temperatures < 35°C

3. Recent cardiotomy

4. History of cardiac transplantation

5. Current pregnancy

6. Contraindication to 9.3 French femoral venous access for placement of intravascular
cooling catheter

7. Hospice designation (either currently in hospice or previously enrolled within the
past 30 days)