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Translational Approaches to Septic Cardiomyopathy (TASC01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03252613
Recruitment Status : Active, not recruiting
First Posted : August 17, 2017
Last Update Posted : December 24, 2018
Sponsor:
Collaborator:
Euan Ashley
Information provided by (Responsible Party):
Samuel Brown, Intermountain Health Care, Inc.

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.

Condition or disease
Cardiomyopathies Sepsis Septic Shock

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Translational Approaches to Septic Cardiomyopathy
Actual Study Start Date : May 19, 2017
Estimated Primary Completion Date : October 27, 2019
Estimated Study Completion Date : October 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy




Primary Outcome Measures :
  1. Correlation of cytokine profile with left ventricular global longitudinal strain [ Time Frame: 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 Outcome Measures :
  1. Adrenergic susceptibility of pluripotent stem cell-derived cardiomyocytes [ Time Frame: Day 1 ]
    This is a laboratory-based outcome, using pluripotent stem cell-derived cardiomyocytes, with exposure to adrenergic agonists and antagonists in vitro



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252613


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
United States, Utah
Intermoutain Medical Center
Murray, Utah, United States, 84157
Sponsors and Collaborators
Samuel Brown
Euan Ashley
Investigators
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Principal Investigator: Samuel Brown, MD Intermountain Health Care, Inc.
Principal Investigator: Euan Ashley, MD Stanford University

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Responsible Party: Samuel Brown, Principal Investigator, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT03252613     History of Changes
Other Study ID Numbers: 1050374
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There will be a database/tissue bank for future research

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samuel Brown, Intermountain Health Care, Inc.:
septic cardiomyopathy
cytokine
iPSC
Inducible pluripotent stem cell
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases