NCT03913403

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

April 10, 2019

Last Update Submit

February 8, 2021

Conditions

Sepsis

Keywords

Fluid ManagementSepsis-Induced HypotensionVasopressorsCardiac Contractility

Outcome Measures

Primary Outcomes (3)

  • Left Ventricular Contractility at 24 hours

    Left Ventricular Global Longitudinal Strain

    24 +/- 6 Hours

  • Right Ventricular Structure at 24 hours

    Right Ventricular End Diastolic Area to Left Ventricular End Diastolic Area Ratio

    24 +/- 6 hours

  • Day 3 delta SOFA

    Difference between baseline and day 3 Sequential Organ Failure Assessment (SOFA) scores

    at 72 hours

Secondary Outcomes (1)

  • Right Ventricular Contractility at 24 hours

    24 +/- 6 hours

Study Arms (1)

Intervention

Participants will receive 2 ECHO's and 2 Blood Draws

Procedure: ECHOProcedure: Blood Draw

Interventions

ECHOPROCEDURE

Echocardiogram at baseline and 24 hours later

Intervention
Blood DrawPROCEDURE

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) Trial with no allergy to ultrasound-enhancing agents

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

NOT YET RECRUITING

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

NOT YET RECRUITING

Oregon Health Sciences Center

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Vanderbilt University

Nashville, Tennessee, 37235, United States

NOT YET RECRUITING

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Harborview Medical Center

Seattle, Washington, 98104, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Samuel Brown, MD

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Aston

CONTACT

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

Carlos Barbagelata, MS

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 12, 2019

Study Start

April 30, 2019

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

Data will be collected electronically and stored at the Coordinating Center at Intermountain Medical Center. A de-identified version of the analytic data-set will be available for use 3 years after the primary publication. Data can be accessed at that point via the National Heart, Lung and Blood Institute (NHLBI) Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) data repository.

Time Frame
A de-identified version of the analytic data-set will be available for use 3 years after the primary publication.
Access Criteria
Investigators who complete the appropriate registrations with the Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) will have access to the de-identified analytic dataset as per BioLINCC policies.
More information

Locations

US(7)