Obesity, Sepsis, Septic Shock
Conditions
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).
Interventions
PROCEDUREActual Body Weight Dosing
30cc/kg initial bolus calculated using Actual Body Weight
PROCEDUREAdjusted Body Weight Dosing
30cc/kg initial bolus calculated using Adjusted Body Weight
PROCEDUREIdeal Body Weight Dosing
30cc/kg initial bolus calculated using Ideal Body Weight
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility1: fluid target | 3 hours | percentage of of patients with actual volume received within 10% of target fluid volume. |
| Safety-ventilation | 24 hours | Proportion of patients requiring invasive or noninvasive mechanical ventilation |
| Safety-vasopressors | 24 hours | proportion of patients requiring vasopressor administration |
| Safety-time to hemodynamic stability | 72 hours | time from randomization to map \>65 without use of vasopressors and no lactate \>2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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: hospital length of stay | 28 days | number of midnights spent in hospital up to 28 days |
| Exploratory: ICU length of stay | 28 days | number of consecutive midnights in ICU |
| feasibility2: recruitment rate | study duration | proportion of patients enrolled out of patients screened to randomized through completion of study, an average of 1 year |
| feasibility3: time to randomization | 3 hours | median time from screening to randomization |
Countries
United States
Outcome results
None listed