Fluid Resuscitation in Septic Shock Patients With BMI Elevation (FRISSBE)

Wake Forest University (WFU)

Status: Terminated

Conditions: Obesity; Septic Shock; Sepsis

Treatments: Procedure: Actual Body Weight Dosing; Procedure: Adjusted Body Weight Dosing; Procedure: Ideal Body Weight Dosing

Study type: Interventional

Funder types: Other

Identifiers

NCT04759989

Fluid resuscitation

Details and patient eligibility

About

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

Full 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).

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 3 patient groups

30cc/kg ideal body weight (IBW)

Active Comparator group

Description:

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)

Treatment:

Procedure: Ideal Body Weight Dosing

30cc/kg adjusted body weight (AdjBW)

Active Comparator group

Description:

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).

Treatment:

Procedure: Adjusted Body Weight Dosing

30cc/kg actual body weight (ABW)

Active Comparator group

Description:

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

Treatment:

Procedure: Actual Body Weight Dosing