Fluid Resuscitation in Septic Shock Patients With BMI Elevation

Not Applicable

Terminated

• Conditions: Septic Shock; Obesity; Sepsis

• Registration Number: NCT04759989
• Lead Sponsor: Wake Forest University Health Sciences

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).

Study Timeline

• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-18
• Study Start: 2021-06-01
• Primary Completion: 2022-04-25
• Study Completion: 2022-05-25
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States