NCT03141255: CHILL-SHOCK

Cardiogenic Shock Intravascular Cooling Trial

Completed NA Results posted Last updated 12 April 2023

What this trial tests

NA trial testing IVTM™ System in Cardiogenic Shock in 20 participants. Completed in 1 November 2021.

Timeline

6 November 2017

Primary endpoint
1 November 2021

1 November 2021

Quick facts

Lead sponsor	University of Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	6 November 2017
Primary completion	1 November 2021
Estimated completion	1 November 2021
Sites	1 location across United States

Drugs / interventions tested

• IVTM™ System
• Quattro® Catheter

Conditions studied

• Cardiogenic Shock — all drugs for Cardiogenic Shock →

Sponsor

University of Chicago

Who can join

Adults 18 to 89, any sex, with Cardiogenic Shock. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Episodes of Arrhythmia Primary · up to 96 hours

requiring intervention (medical therapy or therapy with temporary pacemaker)

Group	Value	95% CI
Control	0
Therapeutic Hypothermia	1

Number of Participants With Bleeding Primary · up to 96 hours

requiring transfusions as a direct result of the cooling catheter insertion or secondary to resulting coagulopathy

Group	Value	95% CI
Control Group	0
Therapeutic Hypothermia	2

Number of Participants With Bloodstream Infection/Suspected Sepsis Primary · up to 96 hours

confirmed with 2 positive blood cultures or sequential organ failure assessment (SOFA) score \>2

Group	Value	95% CI
Control Group	0
Therapeutic Hypothermia	0

Number of Participants With Hypokalemia Primary · up to 96 hours

potassium levels below 3.0mEq/L, not secondary to other identifiable causes

Group	Value	95% CI
Control Group	0
Therapeutic Hypothermia	0

Changes in Cardiac Index Secondary · up to 96 hours

Difference between groups in cardiac index and output

Group	Value	95% CI
Control Group	2.6	2.5 – 3.15
Therapeutic Hypothermia	3.6	3.1 – 3.9

Changes in Systemic Vascular Resistance (SVR) Secondary · up to 96 hours

Mean SVR in population

Group	Value	95% CI
Control Group	965	891 – 1051
Therapeutic Hypothermia	702	667 – 827

Cardiac Power Index Secondary · up to 96 hours

Measured 48-96 hours after randomization

Group	Value	95% CI
Control Group	0.61	0.55 – 0.7
Therapeutic Hypothermia	0.53	0.435 – 0.565

Cumulative Milrinone Dose Secondary · up to 96 hours

cumulative weight adjusted dosing of milrinone

Group	Value	95% CI
Control Group	0.28	0 – 0.578
Therapeutic Hypothermia	0.36	0 – 0.52

Left Ventricular Ejection Fraction Secondary · up to 18-24 hours

percent ejection fraction on echocardiogram at 18-24 hours after randomization

Group	Value	95% CI
Control Group	40.1	36.2 – 40.8
Therapeutic Hypothermia	28.1	22.4 – 62.5

All-cause Mortality Secondary · up to 96 hours, 30 days, and 90 days

All-cause mortality at 90 days was primary outcome/time point of choice.

Group	Value	95% CI
Control Group	3
Therapeutic Hypothermia	4

Cumulative Dobutamine Dose Secondary · 96 hours

Cumulative dose of weight adjusted dobutamine dobutamine

Group	Value	95% CI
Control Group	0	0 – 1.6
Therapeutic Hypothermia	0	0 – 10.75

Cumulative Dopamine Dose Secondary · 96 hours

Cumulative weight adjusted dopamine dose

Group	Value	95% CI
Control Group	0	0 – 0.23
Therapeutic Hypothermia	7.27	0 – 35.28

Adverse events — posted to ClinicalTrials.gov

Time frame: 90 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Group

Serious: 0/10 (0%)

Deaths: 3/10

Therapeutic Hypothermia

Serious: 1/10 (10%)

Deaths: 4/10

Serious adverse events (1 terms)

Reaction	System	Control Group	Therapeutic Hypothermia
Bradycardic Arrest	General disorders	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Control Group	Therapeutic Hypothermia
Bleeding	Blood and lymphatic system disorders	—	—
Shivering	General disorders	—	—
Bradycardia	Cardiac disorders	—	—
Hyperglycemia	Endocrine disorders	—	—
Hypotension	Cardiac disorders	—	—
Non-sustained Ventricular Tachycardia	Cardiac disorders	—	—
Aspiration Event	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Bradycardic Arrest.

Data from ClinicalTrials.gov NCT03141255 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.