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Translational Approaches to Septic Cardiomyopathy

NCT ID: NCT03252613

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-19

Study Completion Date

2019-10-27

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiomyopathies Sepsis Septic Shock

Keywords

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septic cardiomyopathy cytokine iPSC Inducible pluripotent stem cell

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Major cardiac dysrhythmia such as:

* Ventricular tachycardia (V-tach)
* Ventricular Fibrillation (V-fib)
* Third degree heart block (complete hear block or complete AV block)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Euan Ashley

UNKNOWN

Sponsor Role collaborator

Samuel Brown

OTHER

Sponsor Role lead

Responsible Party

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Samuel Brown

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Samuel Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Health Care, Inc.

Euan Ashley, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Intermoutain Medical Center

Murray, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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1050374

Identifier Type: -

Identifier Source: org_study_id