Status:
COMPLETED
Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
Primary Hypothesis: Restrictive (vs liberal) fluid treatment strategy during the first 24 hours of resuscitation for sepsis-induced hypotension will reduce 90-day in-hospital mortality. 1. We will em...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2022
Estimated Enrollment :
1563 Patients enrolled
Trial Details
Trial ID
NCT03434028
Start Date
March 7 2018
End Date
August 24 2022
Last Update
July 6 2023
Active Locations (50)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
UCSF Fresno
Fresno, California, United States, 93701
3
Ronald Reagan UCLA
Los Angeles, California, United States, 90095
4
UCSF San Francisco
San Francisco, California, United States, 94143