Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

Completed · Phase 3

Conditions studied: Septic Shock

In brief

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.

Key facts

Study ID

NCT03434028

Run by

Massachusetts General Hospital

People needed

1563

Starts

2018-03-07

Expected to finish

2022-08-24

Last updated by the study team

2023-07-06

Who can join

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

You may qualify if…

• Age ≥ 18 years
• 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).

You may not qualify if…

• 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

Where it is running

• University of Arizona — Tucson, Arizona, United States
• UCSF Fresno — Fresno, California, United States
• Ronald Reagan UCLA — Los Angeles, California, United States
• UCSF San Francisco — San Francisco, California, United States
• Stanford University Hospital — Stanford, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Denver Health Medical Center — Denver, Colorado, United States
• St. Joseph Hospital — Denver, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• University Medical Center (LSU) — New Orleans, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• St. Vincent Hospital — Worcester, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Mt. Sinai Hospital — New York, New York, United States
• Montefiore Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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