Cardiogenic ShockCHILL-SHOCKNCT03141255
Cardiogenic Shock Intravascular Cooling Trial
A study testing IVTM™ System and Quattro® Catheter in people with Cardiogenic Shock, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- IVTM™ System and Quattro® Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK)
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.
Read the 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.
- Conditions
- Cardiogenic Shock
- Being tested
- IVTM™ System, Quattro® Catheter
- Keywords
- Therapeutic Hypothermia (TH)
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVTM™ SystemDevice
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® CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: IVTM™ System; Device: Quattro® Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Episodes of Arrhythmia
requiring intervention (medical therapy or therapy with temporary pacemaker)
Measured: 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
Measured: 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
Measured: up to 96 hours
Number of Participants With Hypokalemia
potassium levels below 3.0mEq/L, not secondary to other identifiable causes
Measured: up to 96 hours
Secondary outcomes (8)
Changes in Cardiac Index
Difference between groups in cardiac index and output
Measured: up to 96 hours
Changes in Systemic Vascular Resistance (SVR)
Mean SVR in population
Measured: up to 96 hours
Cardiac Power Index
Measured 48-96 hours after randomization
Measured: up to 96 hours
Cumulative Milrinone Dose
cumulative weight adjusted dosing of milrinone
Measured: up to 96 hours
Left Ventricular Ejection Fraction
percent ejection fraction on echocardiogram at 18-24 hours after randomization
Measured: up to 18-24 hours
All-cause Mortality
All-cause mortality at 90 days was primary outcome/time point of choice.
Measured: up to 96 hours, 30 days, and 90 days
Cumulative Dobutamine Dose
Cumulative dose of weight adjusted dobutamine dobutamine
Measured: 96 hours
Cumulative Dopamine Dose
Cumulative weight adjusted dopamine dose
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start6 Nov 2017
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- ZOLL Circulation, Inc., USA
- Responsible party
- Sponsor
- Investigators
- Jonathan D. Paul, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141255
- Sponsor's protocol ID
- IRB16-1728
- Acronym
- CHILL-SHOCK
- Status last verified
- Mar 2023
- First submitted
- 1 May 2017
- Last updated
- 12 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38458486
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK)
- ClinicalTrials.gov ID
- NCT03141255
- Acronym / sponsor ID
- CHILL-SHOCK / IRB16-1728
- Conditions
- Cardiogenic Shock
- Keywords
- Therapeutic Hypothermia (TH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- ZOLL Circulation, Inc., USA
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Posted 12 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients will receive only standard of care treatment for cardiogenic shock. |
| Therapeutic Hypothermia | Experimental | Device: IVTM™ System, Device: Quattro® CatheterPatients 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Cardiogenic shock
- Etiology of shock
- Age ≥ 18 years AND ≤ 89 years
- Admission to the University of Chicago Coronary Care Unit
Key exclusion criteria (7 listed)
- Baseline heart rate < 60 beats per minute
- Baseline temperatures < 35°C
- Recent cardiotomy
- History of cardiac transplantation
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVTM™ SystemTH 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 | Therapeutic Hypothermia |
| Quattro® CatheterTH 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 | Therapeutic Hypothermia |
Primary outcome
Number of Participants With Episodes of Arrhythmia
Time frame: up to 96 hours
requiring intervention (medical therapy or therapy with temporary pacemaker)
Number of Participants With Bleeding
Time frame: up to 96 hours
requiring transfusions as a direct result of the cooling catheter insertion or secondary to resulting coagulopathy
Number of Participants With Bloodstream Infection/Suspected Sepsis
Time frame: up to 96 hours
confirmed with 2 positive blood cultures or sequential organ failure assessment (SOFA) score >2
Number of Participants With Hypokalemia
Time frame: up to 96 hours
potassium levels below 3.0mEq/L, not secondary to other identifiable causes
8 secondary outcomes
Changes in Cardiac Index
Time frame: up to 96 hours
Changes in Systemic Vascular Resistance (SVR)
Time frame: up to 96 hours
Cardiac Power Index
Time frame: up to 96 hours
Cumulative Milrinone Dose
Time frame: up to 96 hours
Left Ventricular Ejection Fraction
Time frame: up to 18-24 hours
All-cause Mortality
Time frame: up to 96 hours, 30 days, and 90 days
Cumulative Dobutamine Dose
Time frame: 96 hours
Cumulative Dopamine Dose
Time frame: 96 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38458486Gupta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan D. Paul principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVTM™ System and Quattro® Catheter in people with Cardiogenic Shock, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Episodes of Arrhythmia (time frame: up to 96 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.