Trial Search Results

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Massachusetts General Hospital

Stanford Investigator(s):

Intervention(s):

  • Drug: Early Vasopressors
  • Drug: Early Fluids

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting