Skip to Main Content
Phase III

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS)

  • Study HIC#:2000023369
  • Last Updated:07/15/2021

Brief Summary:

Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The aim of the study is 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.

  • Age18 years and older
  • GenderBoth
  • Start Date11/05/2018
  • End Date03/30/2021

Trial Purpose and Description

Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The aim of the study is 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.

Eligibility Criteria

Inclusion Criteria:

A suspected or confirmed infection (broadly defined by administration or planned administration of antibiotics)
Sepsis-induced hypotension defined as systolic blood pressure < 100 mmHg or MAP < 65 mmHg after a minimum of at least 1 liter of fluid (*Fluids inclusive of pre-hospital fluids; blood pressure must be below any known or reported pre-morbid baseline).

Exclusion Criteria:

More than 4 hours elapsed since meeting inclusion criteria or 24 hours elapsed since admission to the hospital
Patient already received 3 liters of intravenous fluid (includes prehospital volumes)
Unable to obtain informed consent
Known pregnancy
Hypotension suspected to be due to non-sepsis cause (e.g. hemorrhagic shock)
Blood pressure is at known or reported baseline level
Severe Volume Depletion from an acute condition other than sepsis. In the judgment of the treating physician, the patient has an acute condition other than sepsis causing (or indicative) of *severe volume depletion; Examples include: Diabetic ketoacidosis, high volume vomiting or diarrhea, hyperosmolar hyperglycemic state, and nonexertional hyperthermia (heat stroke); severe is defined by the need for substantial intravenous fluid administration as part of routine clinical care
Pulmonary edema or clinical signs of new fluid overload (e.g. bilateral crackles, new oxygen requirement, new peripheral edema, fluid overload on chest x-ray)
Treating physician unwilling to give additional fluids as directed by the liberal protocol
Treating physician unwilling to use vasopressors as directed by the restrictive protocol.
Current or imminent decision to withhold most/all life-sustaining treatment; this does not exclude those patients committed to full support except cardiopulmonary resuscitation
Immediate surgical intervention planned such that study procedures could not be followed
Prior enrollment in this study 

Sub-Investigators

For more information about this study, contact the Help us Discover team on: