SepsisNCT03913403
Study of Treatment's Echocardiographic Mechanisms
An observational study of Sepsis, run by Intermountain Health Care, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- ECHO and Blood Draw
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Apr 2019to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) Trial with no allergy to ultrasound-enhancing agents
Who may be able to join
- Enrolled in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) Trial
Who cannot join
- Lack of Informed Consent for this Ancillary Study
- Allergy to Ultrasound-Enhancing Agents
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Not yet recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Somnath Bose, MD
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Samuel Brown, MD, 801-507-6556, Samuel.brown@imail.org
Carlos Barbagelata, MS, 801-507-4607, carlos.barbagelata@imail.org
- Not yet recruiting
Vanderbilt University
Nashville, Tennessee, 37235
Wesley Self, MD
Deepak Gupta, MD
- Not yet recruiting
Oregon Health Sciences Center
Portland, Oregon, 97239
Akram Khan, MD
- Not yet recruiting
Harborview Medical Center
Seattle, Washington, 98104
Catherine Hough, MD
Nicholas Johnson, MD
- Not yet recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Michelle Gong, MD
- Not yet recruiting
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Lane Smith, MD
About this study
Official title: Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis: Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM)
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.
Read the detailed description
The Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis: Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM) study is an ancillary study to CLOVERS, a parent multi-center, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The CLOVERS trial attempts to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension. This ancillary study obtains echocardiograms among CLOVERS-enrolled patients who consent to CLOVERS-STEM at baseline and 24 hours later (secondarily, this study also measures serum troponin levels at baseline and 24 hours) to pursue three aims: 1. Evaluate for differences in left ventricular global longitudinal strain at 24 hours after randomization between treatment arms; 2. Evaluate for differences in right ventricular end diastolic area to left ventricular end diastolic area ratio at 24 hours after randomization between treatment arms; 3. Explore possible heterogeneity of treatment effect based on baseline echocardiogram.
- Conditions
- Sepsis
- Being tested
- ECHO, Blood Draw
- Keywords
- Fluid Management, Sepsis-Induced Hypotension, Vasopressors, Cardiac Contractility
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHOProcedure or surgery
Echocardiogram at baseline and 24 hours later
Blood DrawProcedure or surgery
Blood Draw for Troponin Levels - 5ml at baseline and 24 hours later
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Participants will receive 2 ECHO's and 2 Blood Draws Receives: Procedure: ECHO; Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Contractility at 24 hours
Left Ventricular Global Longitudinal Strain
Measured: 24 +/- 6 Hours
Right Ventricular Structure at 24 hours
Right Ventricular End Diastolic Area to Left Ventricular End Diastolic Area Ratio
Measured: 24 +/- 6 hours
Day 3 delta SOFA
Difference between baseline and day 3 Sequential Organ Failure Assessment (SOFA) scores
Measured: at 72 hours
Secondary outcomes (1)
Right Ventricular Contractility at 24 hours
Right Ventricular Longitudinal Strain
Measured: 24 +/- 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start30 Apr 2019
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Montefiore Medical Center, Oregon Health and Science University, Vanderbilt University Medical Center, Wake Forest University Health Sciences, Harborview Injury Prevention and Research Center
- Responsible party
- Sponsor
- Investigators
- Samuel Brown, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913403
- Sponsor's protocol ID
- 1051075
- Status last verified
- Feb 2021
- First submitted
- 10 Apr 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis: Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM)
- ClinicalTrials.gov ID
- NCT03913403
- Acronym / sponsor ID
- 1051075
- Conditions
- Sepsis
- Keywords
- Fluid Management, Sepsis-Induced Hypotension, Vasopressors, Cardiac Contractility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Montefiore Medical Center, Oregon Health and Science University, Vanderbilt University Medical Center, Wake Forest University Health Sciences, Harborview Injury Prevention and Research Center
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis: Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM) study is an ancillary study to CLOVERS, a parent multi-center, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The CLOVERS trial attempts to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension. This ancillary study obtains echocardiograms among CLOVERS-enrolled patients who consent to CLOVERS-STEM at baseline and 24 hours later (secondarily, this study also measures serum troponin levels at baseline and 24 hours) to pursue three aims: 1. Evaluate for differences in left ventricular global longitudinal strain at 24 hours after randomization between treatment arms; 2. Evaluate for differences in right ventricular end diastolic area to left ventricular end diastolic area ratio at 24 hours after randomization between treatment arms; 3. Explore possible heterogeneity of treatment effect based on baseline echocardiogram.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Procedure: ECHO, Procedure: Blood DrawParticipants will receive 2 ECHO's and 2 Blood Draws |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) Trial with no allergy to ultrasound-enhancing agents
Key inclusion criteria (1 listed)
- Enrolled in the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) Trial
Key exclusion criteria (2 listed)
- Lack of Informed Consent for this Ancillary Study
- Allergy to Ultrasound-Enhancing Agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECHOEchocardiogram at baseline and 24 hours later | Procedure or surgery | Intervention |
| Blood DrawBlood Draw for Troponin Levels - 5ml at baseline and 24 hours later | Procedure or surgery | Intervention |
Primary outcome
Left Ventricular Contractility at 24 hours
Time frame: 24 +/- 6 Hours
Left Ventricular Global Longitudinal Strain
Right Ventricular Structure at 24 hours
Time frame: 24 +/- 6 hours
Right Ventricular End Diastolic Area to Left Ventricular End Diastolic Area Ratio
Day 3 delta SOFA
Time frame: at 72 hours
Difference between baseline and day 3 Sequential Organ Failure Assessment (SOFA) scores
1 secondary outcome
Right Ventricular Contractility at 24 hours
Time frame: 24 +/- 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Brown, MD principal investigator
Intermountain Health Care, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Intermountain Health Care, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie Aston (801-507-4607, valerie.aston@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Contractility at 24 hours (time frame: 24 +/- 6 Hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.