Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

Trial ID or NCT#

NCT03434028

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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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Investigator(s)

Angela Rogers
Angela Rogers
Pulmonary critical care specialist, Pulmonologist, Critical care specialist
Associate Professor of Medicine (Pulmonary and Critical Care)

View on ClinicalTrials.gov