Translational Approaches to Septic Cardiomyopathy

NCT03252613 | Unknown

• 1 other identifier: 1050374
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiomyopathies; Sepsis; Septic Shock

Keywords

septic cardiomyopathy; cytokine; iPSC; Inducible pluripotent stem cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adrenergic susceptibility of pluripotent stem cell-derived cardiomyocytes

  Day 1

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age Admitted to the ICU
• SEPSIS PATIENTS:
• Sepsis patients must have:
• Suspected or confirmed infection AND
• Organ dysfunction as defined by a SOFA \>= 2 above baseline (if no baseline data available, SOFA assumed to be 0)
• SEPTIC SHOCK PATIENTS:
• AFTER INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, septic shock patients must have:
• Suspected or confirmed infection AND
• Lactate \> 2 mmol/L AND
• Receiving vasopressors

You may not qualify if:

• Major cardiac dysrhythmia such as:
• Ventricular tachycardia (V-tach)
• Ventricular Fibrillation (V-fib)
• Third degree heart block (complete hear block or complete AV block)

Sponsors & Collaborators

• Samuel Brown: lead
• Euan Ashley: collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

Intermoutain Medical Center

Murray, Utah, 84157, United States

Location

MeSH Terms

Conditions

Cardiomyopathies; Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Samuel Brown, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

• Euan Ashley, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 17, 2017
• Study Start: May 19, 2017
• Primary Completion: October 27, 2019
• Study Completion: October 27, 2019
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

US (2)