StudyFinder
Crystalloids Liberal or Vasopressors Early Resuscitation in Sepsis
OPEN TO ACCRUAL
18 years and over
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
Drug: Early Vasopressors, Drug: Early Fluids, drug: Ringer's (hartmann's) lactate solution, drug: Plasmalyte (crystalloid) solution, drug: Normal (0.9%, isotonic) saline solution, drug: Norepinephrine
Septic Shock, Symptoms, Signs, and lll-Defined Conditions (780-799)
Fluid management, Sepsis-induced hypotension, vasopressors
Mason, Jessica - jessica.mason1@vcuhealth.org
de Wit, Marjolein
III
HM20013528
NCT03434028
See this study on ClinicalTrials.gov