Fluid Resuscitation in Septic Shock Patients With BMI Elevation
Fluid Resuscitation in Septic Shock Patients With BMI Elevation
To explore the safety and feasibility of alternative fluid resuscitation strategies in obese
 patients with septic shock.
Early, goal-directed therapy with timely achievement of hemodynamic stability has been shown
 to clearly improve outcomes in patients with septic shock. Although Surviving Sepsis Campaign
 guidelines recommend a weight-based approach to initial fluid resuscitation (i.e. 30ml/kg),1
 at present, there are no robust data to support whether dosing based on actual body weight or
 an alternative correction formula (ideal body weight, adjusted body weight) is superior.

 FRISSBE is a prospective, randomized, three-arm parallel-group pilot trial of alternative
 resuscitation strategies for obese patients with septic shock, looking at feasibility and
 safety of different weight-based approaches. Subject treatment assignment will not be
 blinded. Data will be collected and analyzed on an intent-to-treat basis. The study will
 enroll 126 subjects, with 42 subjects per treatment arm. Subjects will be randomized to
 receive one of three weight-based initial fluid resuscitation strategies - 30cc/kg ideal body
 weight (IBW), 30cc/kg adjusted body weight (AdjBW), or 30cc/kg actual body weight (ABW).
Inclusion Criteria:

 -  18 years of age or older

 -  BMI > 30

 -  suspected infection, and either:

 -  hypotension (a systolic blood pressure < 90mmHg) or

 -  blood lactate concentration > 4mmol/L

 Exclusion Criteria:

 -  Pregnant

 -  Primary diagnosis of acute cerebral vascular event

 -  Acute coronary syndrome

 -  Acute pulmonary edema

 -  Status asthmaticus

 -  Major cardiac arrhythmia

 -  Active gastrointestinal hemorrhage

 -  Seizures

 -  Drug overdose

 -  Burns or trauma

 -  Requirement for immediate surgery

 -  CD4<50/mm3

 -  Do-not-resuscitate order status

 -  Transferred from another hospital