Recruiting

TreatmentStudy of Treatment's Echocardiographic Mechanisms

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT03913403

Conditions

Sepsis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ECHO

Blood Draw

Study Details

Brief summary:

This ancillary study determines whether the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) \[ClinicalTrials.gov Identifier: NCT03434028\] treatment arms (restrictive fluids strategy vs. liberal fluid strategy) for early sepsis-induced hypotension are associated with differences in cardiac structure and function based on an echocardiogram at 24 hours after randomization. Secondarily, this ancillary study explores possible heterogeneity of treatment effect based on an echocardiogram performed shortly after randomization in CLOVERS.

Conditions

Sepsis

Study ID

NCT03913403

Start date

Apr 30, 2019

Status verified date

Feb, 2021

Completion date

May 1, 2021

Anticipated

Primary completion date

May 1, 2021

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Enrolled in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) Trial

Exclusion Criteria:

Lack of Informed Consent for this Ancillary Study
Allergy to Ultrasound-Enhancing Agents

Study Design

Enrollment

210 participants

Anticipated

Interventions and Outcome Measures

Arms

Intervention

Participants will receive 2 ECHO's and 2 Blood Draws

Interventions

ECHO

Echocardiogram at baseline and 24 hours later

Blood Draw

Blood Draw for Troponin Levels - 5ml at baseline and 24 hours later

Primary outcome measure

Left Ventricular Contractility at 24 hours [ Time Frame: 24 +/- 6 Hours ]
Right Ventricular Structure at 24 hours [ Time Frame: 24 +/- 6 hours ]
Day 3 delta SOFA [ Time Frame: at 72 hours ]

Central Contacts and Locations

Central contacts

Valerie Aston

801-507-4607 valerie.aston@imail.org

Carlos Barbagelata, MS

801-507-4607 carlos.barbagelata@imail.org

Locations

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Samuel Brown, MD

801-507-6556 Samuel.brown@imail.org

Carlos Barbagelata, MS

801-507-4607 carlos.barbagelata@imail.org

Principal Investigator:

Samuel Brown, MD

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Feb 10, 2021

Last verified

Feb, 2021

Keywords

Fluid Management
Sepsis-Induced Hypotension
Vasopressors
Cardiac Contractility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2021-02-10.