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

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ClinicalTrials.gov Identifier: NCT04759989
Recruitment Status : Not yet recruiting
First Posted : February 18, 2021
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
Brice Taylor, Atrium Health

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

Condition or disease Intervention/treatment Phase
Sepsis Septic Shock Obesity Procedure: Actual Body Weight Dosing Procedure: Adjusted Body Weight Dosing Procedure: Ideal Body Weight Dosing Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fluid Resuscitation in Septic Shock Patients With BMI Elevation
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight Shock

Arm Intervention/treatment
Active Comparator: 30cc/kg ideal body weight (IBW)

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
30cc/kg initial bolus calculated using Ideal Body Weight

Active Comparator: 30cc/kg adjusted body weight (AdjBW)

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
30cc/kg initial bolus calculated using Adjusted Body Weight

Active Comparator: 30cc/kg actual body weight (ABW)

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
30cc/kg initial bolus calculated using Actual Body Weight




Primary Outcome Measures :
  1. Feasibility1: fluid target [ Time Frame: 3 hours ]
    percentage of of patients with actual volume received within 10% of target fluid volume.

  2. Safety-ventilation [ Time Frame: 24 hours ]
    Proportion of patients requiring invasive or noninvasive mechanical ventilation

  3. Safety-vasopressors [ Time Frame: 24 hours ]
    proportion of patients requiring vasopressor administration

  4. Safety-time to hemodynamic stability [ Time Frame: 72 hours ]
    time from randomization to map >65 without use of vasopressors and no lactate >2


Secondary Outcome Measures :
  1. Exploratory: in-hospital all cause mortality [ Time Frame: 28 days ]
    Proportion of patient in each group who experience death due to any cause during hospitalization up to 28 days

  2. Exploratory: ICU length of stay [ Time Frame: 28 days ]
    number of consecutive midnights in ICU

  3. feasibility2: recruitment rate [ Time Frame: study duration ]
    proportion of patients enrolled out of patients screened to randomized through completion of study, an average of 1 year

  4. feasibility3: time to randomization [ Time Frame: 3 hours ]
    median time from screening to randomization

  5. Exploratory: hospital length of stay [ Time Frame: 28 days ]
    number of midnights spent in hospital up to 28 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04759989


Contacts
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Contact: Brice Taylor, MD 8139447050 brice.taylor@atriumhealth.org

Locations
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United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Contact: Brice Taylor, MD    813-944-7050    brice.taylor@atriumhealth.org   
Sub-Investigator: Michael Runyon, MD         
Sub-Investigator: Stephanie Taylor, MD         
Sponsors and Collaborators
Atrium Health
Investigators
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Principal Investigator: Brice Taylor, MD Atrium Health
Publications:
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255.

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Responsible Party: Brice Taylor, Principal investigator, Pulmonary and Critical Care, Atrium Health
ClinicalTrials.gov Identifier: NCT04759989    
Other Study ID Numbers: Fluid resuscitation
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation