Cardiogenic Shock Intravascular Cooling Trial

  • STATUS
    Recruiting
  • End date
    Jul 26, 2021
  • participants needed
    20
  • sponsor
    University of Chicago
Updated on 26 January 2021
heart failure
systolic blood pressure
myocarditis
stemi
cardiomyopathy
vasopressor
acute coronary syndrome
intraaortic balloon pumping
inotropic agent

Summary

The purpose of the study is to compare patients with cardiogenic shock who receive standard therapy plus therapeutic hypothermia (TH) to patients with cardiogenic shock who receive standard medical therapy alone in order to assess the safety of TH in patients with cardiogenic shock. This study will also help understand the physiologic effects of TH in patients with cardiogenic shock. This will be a pilot study to establish the initial safety of TH and to assess tolerability of TH in this patient population.

Description

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 32-34C 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.

Details
Condition Cardiogenic shock
Treatment IVTM™ System, Quattro® Catheter
Clinical Study IdentifierNCT03141255
SponsorUniversity of Chicago
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 89 yrs?
Gender: Male or Female
Do you have Cardiogenic shock?
Do you have any of these conditions: Do you have Cardiogenic shock??
Cardiogenic shock
Systolic blood pressure <90mmHg for at least 30 minutes
Cardiac Index < 2.2 L/min/m2
Pulmonary capillary wedge pressure (PCWP) 15mmHg
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
Etiology of shock
Acute coronary syndromes (STEMI, NSTEMI, or UA)
Ischemic or non-ischemic cardiomyopathy
Myocarditis
Hypertrophic cardiomyopathy
Stress-induced cardiomyopathy
Peripartum cardiomyopathy
Cardiogenic shock in a patient with heart failure with preserved ejection fraction
Age 18 years AND 89 years
Admission to the University of Chicago Coronary Care Unit

Exclusion Criteria

Baseline heart rate < 60 beats per minute
Baseline temperatures < 35C
Recent cardiotomy
History of cardiac transplantation
Current pregnancy
Contraindication to 9.3 French femoral venous access for placement of intravascular cooling catheter
Hospice designation (either currently in hospice or previously enrolled within the past 30 days)
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