Fluid Resuscitation in Septic Shock Patients With BMI Elevation

Not Applicable

Terminated

Interventions: Procedure: Ideal Body Weight Dosing
Procedure: Adjusted Body Weight Dosing
Procedure: Actual Body Weight Dosing

Brief Summary: To explore the safety and feasibility of alternative fluid resuscitation strategies in obese patients with septic shock.

Detailed Description: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
30cc/kg ideal body weight (IBW)	Ideal Body Weight Dosing	30cc/kg intravenous fluids based on the patients calculated ideal body weight will be administered when randomized to this arm Using Devine's formula. (men: 50kg + 2.3kg \* (height(in) - 60); women: 45.5kg + 2.3kg \* (height(in) - 60)
30cc/kg adjusted body weight (AdjBW)	Adjusted Body Weight Dosing	30cc/kg intravenous fluids based on the patients calculated adjusted body weight will be administered when randomized to this arm Calculated by the following formula: AdjBW = IBW + 0.4(ABW - IBW).
30cc/kg actual body weight (ABW)	Actual Body Weight Dosing	30cc/kg intravenous fluids based on the patients actual body weight will be administered when randomized to this arm Patients will receive an initial fluid bolus of 30 cc/kg of actual body weight

Primary Outcome Measures

Name	Time	Method
Safety-time to hemodynamic stability	72 hours	time from randomization to map \>65 without use of vasopressors and no lactate \>2
Feasibility1: fluid target	3 hours	percentage of of patients with actual volume received within 10% of target fluid volume.
Safety-vasopressors	24 hours	proportion of patients requiring vasopressor administration
Safety-ventilation	24 hours	Proportion of patients requiring invasive or noninvasive mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
feasibility2: recruitment rate	study duration	proportion of patients enrolled out of patients screened to randomized through completion of study, an average of 1 year
Exploratory: in-hospital all cause mortality	28 days	Proportion of patient in each group who experience death due to any cause during hospitalization up to 28 days
Exploratory: ICU length of stay	28 days	number of consecutive midnights in ICU
feasibility3: time to randomization	3 hours	median time from screening to randomization
Exploratory: hospital length of stay	28 days	number of midnights spent in hospital up to 28 days

Locations (1): Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States