Cardiogenic Shock Intravascular Cooling Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK)

Conditions
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Cardiogenic Shock

Intervention / Treatment
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* Device: IVTM™ System
* Device: Quattro® Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 < 35°C 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients will receive only standard of care treatment for cardiogenic shock. | |
| Experimental: Therapeutic Hypothermia<br>Patients will be cooled to between 32°C and 34°C using the IVTM™ System and the Quattro® Catheter in addition to receiving standard of care treatment for cardiogenic shock. | Device: IVTM™ System<br>* TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.<br>Device: Quattro® Catheter<br>* TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Episodes of Arrhythmia | requiring intervention (medical therapy or therapy with temporary pacemaker) | up to 96 hours | 
| Number of Participants With Bleeding | requiring transfusions as a direct result of the cooling catheter insertion or secondary to resulting coagulopathy | up to 96 hours | 
| Number of Participants With Bloodstream Infection/Suspected Sepsis | confirmed with 2 positive blood cultures or sequential organ failure assessment (SOFA) score >2 | up to 96 hours | 
| Number of Participants With Hypokalemia | potassium levels below 3.0mEq/L, not secondary to other identifiable causes | up to 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Cardiac Index | Difference between groups in cardiac index and output | up to 96 hours | 
| Changes in Systemic Vascular Resistance (SVR) | Mean SVR in population | up to 96 hours | 
| Cardiac Power Index | Measured 48-96 hours after randomization | up to 96 hours | 
| Cumulative Milrinone Dose | cumulative weight adjusted dosing of milrinone | up to 96 hours | 
| Left Ventricular Ejection Fraction | percent ejection fraction on echocardiogram at 18-24 hours after randomization | up to 18-24 hours | 
| All-cause Mortality | All-cause mortality at 90 days was primary outcome/time point of choice. | up to 96 hours, 30 days, and 90 days | 
| Cumulative Dobutamine Dose | Cumulative dose of weight adjusted dobutamine dobutamine | 96 hours | 
| Cumulative Dopamine Dose | Cumulative weight adjusted dopamine dose | 96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic Hypothermia (TH)