N/A N=20 Randomized Treatment

Cardiogenic Shock Intravascular Cooling Trial

Cardiogenic Shock

Bottom Line

View on ClinicalTrials.gov: NCT03141255 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Apr 2023

Primary outcome: Primary: Number of Participants With Episodes of Arrhythmia — 0; 1 Participants — p=1

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: IVTM™ System (Device); Quattro® Catheter (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Chicago
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Episodes of Arrhythmia	0; 1	1
PRIMARY Number of Participants With Bleeding	0; 2	0.47
PRIMARY Number of Participants With Bloodstream Infection/Suspected Sepsis	0; 0	1
PRIMARY Number of Participants With Hypokalemia	0; 0	1
SECONDARY Changes in Cardiac Index	2.6; 3.6	0.029 sig
SECONDARY Changes in Systemic Vascular Resistance (SVR)	965; 702	0.091
SECONDARY Cardiac Power Index	0.61; 0.53	0.029 sig
SECONDARY Cumulative Milrinone Dose	0.28; 0.36	0.7
SECONDARY Left Ventricular Ejection Fraction	40.1; 28.1	0.516
SECONDARY All-cause Mortality	3; 4	0.75
SECONDARY Cumulative Dobutamine Dose	0; 0	0.43
SECONDARY Cumulative Dopamine Dose	0; 7.27	0.052

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.

Eligibility Criteria

Inclusion Criteria

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
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

Exclusion Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03141255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.