Translational Approaches to Septic Cardiomyopathy (TASC01)

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Septic Shock; Cardiomyopathies

• Study Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Utah
    • Murray, Utah, United States, 84157
      • Intermoutain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population of study subjects must be 18 years of age, admitted to an ICU and have sepsis or septic shock as defined in the above inclusion criteria.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Samuel Brown
• Collaborators: Euan Ashley
• Investigators: Principal Investigator: Euan Ashley, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2017
• Primary Completion (Anticipated): October 27, 2019
• Study Completion (Anticipated): October 27, 2019

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: cytokine; iPSC; septic cardiomyopathy; Inducible pluripotent stem cell
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: 1050374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There will be a database/tissue bank for future research

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No