Fluid Resuscitation in Septic Shock Patients With BMI Elevation — FRISSBE  

Obesity Clinical Trial

Official title: Fluid Resuscitation in Septic Shock Patients With BMI Elevation

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Obesity
• Sepsis
• Septic Shock
• Shock
• Shock, Septic

• NCT number: NCT04759989
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2021
• Completion date: May 25, 2022