NCT04759989

Fluid Resuscitation in Septic Shock Patients With BMI Elevation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Sepsis
• Septic Shock
• Obesity

Interventions

Type	Name	Description
PROCEDURE	Actual Body Weight Dosing	30cc/kg initial bolus calculated using Actual Body Weight
PROCEDURE	Adjusted Body Weight Dosing	30cc/kg initial bolus calculated using Adjusted Body Weight
PROCEDURE	Ideal Body Weight Dosing	30cc/kg initial bolus calculated using Ideal Body Weight

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-04-25
• Completion: 2022-05-25
• First posted: 2021-02-18
• Last updated: 2022-08-15

Locations

1 site across 1 country: United States