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Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK)

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ClinicalTrials.gov Identifier: NCT03141255
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : June 1, 2018
Sponsor:
Collaborator:
ZOLL Circulation, Inc., USA
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Device: IVTM™ System Device: Quattro® Catheter Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK)
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia Shock

Arm Intervention/treatment
No Intervention: Control Group
Patients will receive only standard of care treatment for cardiogenic shock.
Experimental: Therapeutic Hypothermia
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
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.

Device: Quattro® Catheter
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.




Primary Outcome Measures :
  1. Episodes of arrhythmia [ Time Frame: up to 96 hours ]
    requiring intervention (medical therapy or therapy with temporary pacemaker)

  2. Bleeding [ Time Frame: up to 96 hours ]
    requiring transfusions as a direct result of the cooling catheter insertion or secondary to resulting coagulopathy

  3. Bloodstream infection/suspected sepsis [ Time Frame: up to 96 hours ]
    confirmed with 2 positive blood cultures or sequential organ failure assessment (SOFA) score >2

  4. Hypokalemia [ Time Frame: up to 96 hours ]
    potassium levels below 3.0mEq/L, not secondary to other identifiable causes


Secondary Outcome Measures :
  1. Changes in cardiac output/cardiac index [ Time Frame: up to 96 hours ]
  2. Changes in pulmonary capillary wedge pressure (PCWP) [ Time Frame: up to 96 hours ]
  3. Changes in systemic vascular resistance (SVR) [ Time Frame: up to 96 hours ]
  4. Changes in mixed venous oxygen saturation (MVO2) [ Time Frame: up to 96 hours ]
  5. Changes in cardiac power index [ Time Frame: up to 96 hours ]
  6. Cumulative vasopressor and inotrope dose requirements [ Time Frame: up to 96 hours ]
    number of vasoactive and/or inotropic drugs used

  7. ECG changes [ Time Frame: up to 18-24 hours ]
    percent change in ejection fraction

  8. All-cause mortality [ Time Frame: up to 96 hours, 30 days, and 90 days ]


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141255


Contacts
Contact: Jonathan D. Paul, MD 773-834-1497 jpaul@medicine.bsd.uchicago.edu
Contact: Rohan J. Kalathiya, MD rohan.kalathiya@uchospitals.edu

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Jonathan D. Paul, MD    773-834-1497    jpaul@medicine.bsd.uchicago.edu   
Contact: Rohan J. Kalathiya, MD       rohan.kalathiya@uchospitals.edu   
Sponsors and Collaborators
University of Chicago
ZOLL Circulation, Inc., USA
Investigators
Principal Investigator: Jonathan D. Paul University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03141255     History of Changes
Other Study ID Numbers: IRB16-1728
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by University of Chicago:
Therapeutic Hypothermia (TH)

Additional relevant MeSH terms:
Shock
Shock, Cardiogenic
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases