Cardiogenic Shock Intravascular Cooling Trial
Condition: Cardiogenic Shock
MeSH terms: Shock, Cardiogenic; Shock
Study type: Interventional

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.
    

Intervention name(s): IVTM™ System; Quattro® Catheter
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Therapeutic Hypothermia (TH)