Clinical trial NCT03141255: Cardiogenic Shock Intravascular Cooling Trial
Official title: Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiogenic Shock
Keywords: Therapeutic Hypothermia (TH)
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: ZOLL Circulation, Inc., USA
First posted: 2017-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 32-34°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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Episodes of Arrhythmia
timeFrame: up to 96 hours
measure: Number of Participants With Bleeding
timeFrame: up to 96 hours
measure: Number of Participants With Bloodstream Infection/Suspected Sepsis
timeFrame: up to 96 hours
measure: Number of Participants With Hypokalemia
timeFrame: up to 96 hours
Secondary outcomes:
measure: Changes in Cardiac Index
timeFrame: up to 96 hours
measure: Changes in Systemic Vascular Resistance (SVR)
timeFrame: up to 96 hours
measure: Cardiac Power Index
timeFrame: up to 96 hours
measure: Cumulative Milrinone Dose
timeFrame: up to 96 hours
measure: Left Ventricular Ejection Fraction
timeFrame: up to 18-24 hours
measure: All-cause Mortality
timeFrame: up to 96 hours, 30 days, and 90 days
measure: Cumulative Dobutamine Dose
timeFrame: 96 hours
measure: Cumulative Dopamine Dose
timeFrame: 96 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jonathan D. Paul
role: PRINCIPAL_INVESTIGATOR
References: