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 60 subjects, with 20 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
30cc/kg initial bolus calculated using Actual Body Weight
30cc/kg initial bolus calculated using Adjusted Body Weight
30cc/kg initial bolus calculated using Ideal Body Weight
Carolinas Medical Center
Charlotte, North Carolina, United States
Feasibility1: fluid target
percentage of of patients with actual volume received within 10% of target fluid volume.
Time frame: 3 hours
Safety-ventilation
Proportion of patients requiring invasive or noninvasive mechanical ventilation
Time frame: 24 hours
Safety-vasopressors
proportion of patients requiring vasopressor administration
Time frame: 24 hours
Safety-time to hemodynamic stability
time from randomization to map \>65 without use of vasopressors and no lactate \>2
Time frame: 72 hours
Exploratory: in-hospital all cause mortality
Proportion of patient in each group who experience death due to any cause during hospitalization up to 28 days
Time frame: 28 days
Exploratory: ICU length of stay
number of consecutive midnights in ICU
Time frame: 28 days
feasibility2: recruitment rate
proportion of patients enrolled out of patients screened to randomized through completion of study, an average of 1 year
Time frame: study duration
feasibility3: time to randomization
median time from screening to randomization
Time frame: 3 hours
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Exploratory: hospital length of stay
number of midnights spent in hospital up to 28 days
Time frame: 28 days