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Crystalloid

Restrictive Fluids for Septic Shock (CLOVERS Trial)

Phase 3

Waitlist Available

Led By David Alan Schoenfeld, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study day 2 through day 28

Awards & highlights

CLOVERS Trial Summary

This trial is studying two different ways to treat sepsis-induced hypotension in adults. One way is to give fluids first, then vasopressors if needed. The other way is to give vasopressors first, then fluids if needed.

Eligible Conditions

Septic Shock

CLOVERS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study day 2 through day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study day 2 through day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study day 2 through day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Death Before Discharge Home by Day 90

Secondary outcome measures

Change in SOFA (Sepsis Related Organ Failure Assessment) Score

Death From Any Cause at Any Location by Day 90

Development of ARDS

+10 more

CLOVERS Trial Design

2Treatment groups

Experimental Treatment

Group I: Restrictive FluidsExperimental Treatment1 Intervention

The general approach will be to use vasopressors to treat hypotension as opposed to intravenous fluids. Maintenance fluids should not be used.

Group II: Liberal FluidsExperimental Treatment1 Intervention

The general approach is to use fluid boluses to treat hypotension.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Early Vasopressors

2018

Completed Phase 3

~1570

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Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,925 Previous Clinical Trials

13,196,341 Total Patients Enrolled

David Alan Schoenfeld, PhDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any documented risks associated with this treatment?

"The safety of this treatment, as rated by our team at Power, falls on the higher end of the spectrum at a 3. This is due to the fact that this is a Phase 3 trial, which contains data that not only supports efficacy, but also multiple rounds of data affirming safety."

Answered by AI

In how many different communities is this research being conducted?

"Including UPMC Presbyterian in Pittsburgh, Harborview Medical Center in Seattle, and University Virginia Medical Center in Charlottesville, this clinical trial has a total of 49 recruitment sites."

Answered by AI

Can people sign up for this test right now?

"Unfortunately, this study is not looking for new enrollees at the moment. According to the information found on clinicaltrials.gov, this trial was first posted on March 7th, 2018 and had its most recent update on June 14th, 2022. However, there are 228 other trials that are currently looking for participants."

Answered by AI

Recent research and studies

Annals of Emergency MedicineJournal

Liberal Versus Restrictive Intravenous Fluid Therapy for Early Septic Shock: Rationale for a Randomized Trial

Self, Wesley H., Matthew W. Semler, Rinaldo Bellomo, Samuel M. Brown, Bennett P. deBoisblanc, Matthew C. Exline, Adit A. Ginde, et al.. 2018. “Liberal Versus Restrictive Intravenous Fluid Therapy for Early Septic Shock: Rationale for a Randomized Trial”. Annals of Emergency Medicine. Elsevier BV. doi:10.1016/j.annemergmed.2018.03.039.

clinicaltrials.govStudy

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

Boyd Taylor Thompson 2018. "Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03434028.