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| Name | Class |
|---|---|
| ZOLL Circulation, Inc., USA | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Patients will receive only standard of care treatment for cardiogenic shock. | |
| Therapeutic Hypothermia | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVTM™ System | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Cardiogenic shock
Etiology of shock
Age ≥ 18 years AND ≤ 89 years
Admission to the University of Chicago Coronary Care Unit
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan D. Paul | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38458486 | Derived | Gupta N, Kalathiya RJ, Singh N, Bandealy N, Neyestanak M, Besser S, Arevalo C, Friant J, Blair JEA, Nathan S, Shah AP, Paul J. Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK). J Card Fail. 2024 Jul;30(7):952-957. doi: 10.1016/j.cardfail.2024.02.017. Epub 2024 Mar 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Patients will receive only standard of care treatment for cardiogenic shock. |
| FG001 | 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. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Patients will receive only standard of care treatment for cardiogenic shock. |
| BG001 | 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. 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Episodes of Arrhythmia | requiring intervention (medical therapy or therapy with temporary pacemaker) | Posted | Count of Participants | Participants | up to 96 hours |
|
90 days
Adverse events were systematically collected and analyzed for these inpatient clinical trial participants. Changes in vitals, clinical condition, need for transfusions, and other events were reported by managing team to trial coordinators. Each relevant event was discussed with the data safety monitoring board.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Patients will receive only standard of care treatment for cardiogenic shock. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardic Arrest | General disorders | Systematic Assessment | Patient underwent bradycardia with subsequent PEA arrest during rewarming after cooling. This was classified as a serious adverse event which was deemed to be possibly related to the trial by the Data Safety Monitoring Board (DSMB) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment | 2 patients had mild bleeding with 2-4u transfusion requirements during hospitalization. Both events were deemed as possibly related to trial. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan D. Paul, MD | The University of Chicago | (773) 702-9461 | jpaul@bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2018 | Jan 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Quattro® Catheter | Device | 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. |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline Creatinine | Median | Inter-Quartile Range | mg/dL |
|
| BMI (kg/mg) | Mean | Standard Deviation | kg/m^2 |
|
| Ejection Fraction on initial "TTE" | Deviation from the protocol, 2/10 control patients have TTE performed at the base line. | Mean | Standard Deviation | percentage of ejection fraction |
|
| Admission NT-proBNP | Deviation from the protocol, 4/10 control patients and 6/10 Therapeutic Hypothermia patients have TTE performed at the base line. | Mean | Standard Deviation | pg/mL |
|
| CAD | Count of Participants | Participants |
|
| DM | Count of Participants | Participants |
|
| HTN | Count of Participants | Participants |
|
| CVA | Count of Participants | Participants |
|
| Atrial fibrillation | Count of Participants | Participants |
|
| Beta-blockers | Count of Participants | Participants |
|
| ACEi | Count of Participants | Participants |
|
| ARB | Count of Participants | Participants |
|
| Neprilysin Inhibitor | Count of Participants | Participants |
|
| ASA | Count of Participants | Participants |
|
| Anti-platelet agent | Count of Participants | Participants |
|
| Statin | Count of Participants | Participants |
|
| Diuretic | Count of Participants | Participants |
|
| Antiarrhythmic | Count of Participants | Participants |
|
| Inotropic support prior to enrollment | Count of Participants | Participants |
|
| Mechanical Circulatory Support prior to enrollment | Count of Participants | Participants |
|
| IABP | Count of Participants | Participants |
|
| ACS | Count of Participants | Participants |
|
| Acute on Chronic ICM/NICM | Count of Participants | Participants |
|
| Mechanical Ventilation | Count of Participants | Participants |
|
|
|
|
| Primary | Number of Participants With Bleeding | requiring transfusions as a direct result of the cooling catheter insertion or secondary to resulting coagulopathy | Posted | Count of Participants | Participants | up to 96 hours |
|
|
|
|
| Primary | Number of Participants With Bloodstream Infection/Suspected Sepsis | confirmed with 2 positive blood cultures or sequential organ failure assessment (SOFA) score >2 | Posted | Count of Participants | Participants | up to 96 hours |
|
|
|
|
| Primary | Number of Participants With Hypokalemia | potassium levels below 3.0mEq/L, not secondary to other identifiable causes | Posted | Count of Participants | Participants | up to 96 hours |
|
|
|
|
| Secondary | Changes in Cardiac Index | Difference between groups in cardiac index and output | Posted | Mean | Inter-Quartile Range | Liter/minute/m^2 | up to 96 hours |
|
|
|
|
| Secondary | Changes in Systemic Vascular Resistance (SVR) | Mean SVR in population | Posted | Mean | Inter-Quartile Range | mm Hg*min/mL | up to 96 hours |
|
|
|
|
| Secondary | Cardiac Power Index | Measured 48-96 hours after randomization | Posted | Mean | Inter-Quartile Range | W/m^2 | up to 96 hours |
|
|
|
|
| Secondary | Cumulative Milrinone Dose | cumulative weight adjusted dosing of milrinone | Posted | Mean | Inter-Quartile Range | mg/kg | up to 96 hours |
|
|
|
|
| Secondary | Left Ventricular Ejection Fraction | percent ejection fraction on echocardiogram at 18-24 hours after randomization | Posted | Mean | Inter-Quartile Range | percent | up to 18-24 hours |
|
|
|
|
| Secondary | All-cause Mortality | All-cause mortality at 90 days was primary outcome/time point of choice. | Posted | Count of Participants | Participants | up to 96 hours, 30 days, and 90 days |
|
|
|
|
| Secondary | Cumulative Dobutamine Dose | Cumulative dose of weight adjusted dobutamine dobutamine | All trial participants | Posted | Median | Inter-Quartile Range | mg/kg | 96 hours |
|
|
|
|
| Secondary | Cumulative Dopamine Dose | Cumulative weight adjusted dopamine dose | All patients in study were analyzed | Posted | Median | Inter-Quartile Range | mg/kg | 96 hours |
|
|
|
|
| 3 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. 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. 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. | 4 | 10 | 1 | 10 | 8 | 10 |
|
|
| Bradycardia | Cardiac disorders | Systematic Assessment | Bradycardia during cooling, improved with discontinuation of amiodarone |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment | Worsening hyperglycemia during cooling in a patient with a history of DM2. Deemed as possibly related to trial. |
|
| Hypotension | Cardiac disorders | Systematic Assessment | Patient had hypotension during cooling requiring pressors. |
|
| Non-sustained Ventricular Tachycardia | Cardiac disorders | Systematic Assessment | Patient had NSVT after trial enrollment deemed possibly related to the trial |
|
| Shivering | General disorders | Systematic Assessment | Shivering related to cooling that was treated with warming blankets and sedation, cessation of cooling was not required |
|
| Aspiration Event | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Patient had aspiration during cooling with subsequent concern for sepsis without positive blood cultures. This was classified as a possibly related adverse event |
|
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| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|