Cardiogenic Shock Intravascular Cooling Trial

NCT03141255 | Completed Results DMC FDA Device

• 1 other identifier: IRB16-1728
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiogenic Shock

Keywords

Therapeutic Hypothermia (TH)

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (8)

• Changes in Cardiac Index

  up to 96 hours

• Changes in Systemic Vascular Resistance (SVR)

  up to 96 hours

• Cardiac Power Index

  up to 96 hours

• Cumulative Milrinone Dose

  up to 96 hours

• Left Ventricular Ejection Fraction

  up to 18-24 hours

Study Arms (2)

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.

Device: IVTM™ System; Device: Quattro® Catheter

Interventions

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.

Therapeutic Hypothermia

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.

Therapeutic Hypothermia

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead
• ZOLL Circulation, Inc., USA: collaborator

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Results Point of Contact

• Title: Jonathan D. Paul, MD
• Organization: The University of Chicago

jpaul@bsd.uchicago.edu

(773) 702-9461

Study Officials

• Jonathan D. Paul

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 5, 2017
• Study Start: November 6, 2017
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 12, 2023
• Results First Posted: April 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)