Translational Approaches to Septic Cardiomyopathy

Sepsis Clinical Trial

— TASC01  

Official title:

Translational Approaches to Septic Cardiomyopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03252613
• Other study ID #: 1050374
• Status: Active, not recruiting
• Start date: May 19, 2017
• Est. completion date: October 27, 2019

Study information

• Verified date: December 2018
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This translational study will assess the association between septic cardiomyopathy (measured via left ventricular global longitudinal strain) and (a) inflammatory cytokine profiles, and (b) the behavior of cardiomyocytes derived from inducible pluripotent stem cells.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: October 27, 2019
• Est. primary completion date: October 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA

At least 18 years of age Admitted to the ICU

SEPSIS PATIENTS:

Sepsis patients must have:

1. Suspected or confirmed infection AND

2. Organ dysfunction as defined by a SOFA >= 2 above baseline (if no baseline data available, SOFA assumed to be 0)

OR

SEPTIC SHOCK PATIENTS:

AFTER INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, septic shock patients must have:

1. Suspected or confirmed infection AND

2. Lactate > 2 mmol/L AND

3. Receiving vasopressors

EXCLUSION CRITERIA Known pregnancy Primary diagnosis of acute coronary syndrome Known preexisting heart disease Known severe valvular disease (regurgitation or stenosis)

Major cardiac dysrhythmia such as:

• Ventricular tachycardia (V-tach)

• Ventricular Fibrillation (V-fib)

• Third degree heart block (complete hear block or complete AV block)

Related Conditions & MeSH terms

• Cardiomyopathies
• Sepsis
• Septic Shock
• Shock, Septic

Locations

Country	Name	City	State
United States	Intermoutain Medical Center	Murray	Utah
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Samuel Brown	Euan Ashley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of cytokine profile with left ventricular global longitudinal strain	This outcome assesses the correlation between inflammatory cytokines (summarized via PCA) and septic cardiomyopathy, as assessed by left ventricular global longitudinal strain.	Day 1
Secondary	Adrenergic susceptibility of pluripotent stem cell-derived cardiomyocytes	This is a laboratory-based outcome, using pluripotent stem cell-derived cardiomyocytes, with exposure to adrenergic agonists and antagonists in vitro	Day 1