Fluid Resuscitation in Septic Shock Patients With BMI Elevation

Study Overview
=================
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).

Official Title
-----------------
Fluid Resuscitation in Septic Shock Patients With BMI Elevation

Conditions
-----------------
Sepsis, Obesity, Septic Shock

Intervention / Treatment
-----------------
* Procedure: Actual Body Weight Dosing
* Procedure: Adjusted Body Weight Dosing
* Procedure: Ideal Body Weight Dosing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 30cc/kg ideal body weight (IBW)<br>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) | Procedure: Ideal Body Weight Dosing<br>* 30cc/kg initial bolus calculated using Ideal Body Weight<br>|
| Active Comparator: 30cc/kg adjusted body weight (AdjBW)<br>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). | Procedure: Adjusted Body Weight Dosing<br>* 30cc/kg initial bolus calculated using Adjusted Body Weight<br>|
| Active Comparator: 30cc/kg actual body weight (ABW)<br>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 | Procedure: Actual Body Weight Dosing<br>* 30cc/kg initial bolus calculated using Actual Body Weight<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 28 days | 
| Exploratory: ICU length of stay | number of consecutive midnights in ICU | 28 days | 
| feasibility2: recruitment rate | proportion of patients enrolled out of patients screened to randomized through completion of study, an average of 1 year | study duration | 
| feasibility3: time to randomization | median time from screening to randomization | 3 hours | 
| Exploratory: hospital length of stay | number of midnights spent in hospital up to 28 days | 28 days |