Translational Approaches to Septic Cardiomyopathy

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03252613

Acronym

TASC01

Enrollment

Registered

2017-08-17

Start date

2017-05-19

Completion date

2019-10-27

Last updated

2018-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathies, Sepsis, Septic Shock

Keywords

septic cardiomyopathy, cytokine, iPSC, Inducible pluripotent stem cell

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Correlation of cytokine profile with left ventricular global longitudinal strain	Day 1	This outcome assesses the correlation between inflammatory cytokines (summarized via PCA) and septic cardiomyopathy, as assessed by left ventricular global longitudinal strain.

Secondary

Measure	Time frame	Description
Adrenergic susceptibility of pluripotent stem cell-derived cardiomyocytes	Day 1	This is a laboratory-based outcome, using pluripotent stem cell-derived cardiomyocytes, with exposure to adrenergic agonists and antagonists in vitro

Countries

United States

Outcome results