Translational Approaches to Septic Cardiomyopathy | NCT03252613

Studies
Translational Approaches to Septic Cardiomyopathy

NCT03252613

Sponsor

Samuel Brown

Status

Unknown status

Last Update Posted

Dec 24, 2018Actual

Enrollment

24Estimated

Phase

Not provided

Conditions

Cardiomyopathies
Sepsis
Septic Shock

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 19, 2017Actual

Primary Completion Date

Oct 27, 2019Estimated

Completion Date

Oct 27, 2019Estimated

First Submitted Date

Aug 15, 2017

First Submission Date that Met QC Criteria

Aug 15, 2017

First Posted Date

Aug 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2018

Last Update Posted Date

Dec 24, 2018Actual

Name	Class
Euan Ashley	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA

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

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samuel Brown, MD	Intermountain Health Care, Inc.	Principal Investigator
Euan Ashley, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Stanford	California	94305	United States
Intermoutain Medical Center

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

There will be a database/tissue bank for future research

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009202	Cardiomyopathies
D018805	Sepsis
D012772	Shock, Septic

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome

Browse Leaves

Not provided

Browse Branches

Not provided