Study of Treatment's Echocardiographic Mechanisms

Status unconfirmed

Conditions studied: Sepsis

In brief

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.

Key facts

Study ID

NCT03913403

Run by

Intermountain Health Care, Inc.

People needed

210

Starts

2019-04-30

Expected to finish

2021-05-01

Last updated by the study team

2021-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Intermountain Medical Center — Murray, Utah, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Harborview Medical Center — Seattle, Washington, United States
• Oregon Health Sciences Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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