Open Actively Recruiting

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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).

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

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Study Stats
Protocol No.
18-000466
Category
Emergency Medicine
Contact
Julia Vargas
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03434028
For detailed technical eligibility, visit ClinicalTrials.gov.