Fluid Resuscitation in Septic Shock Patients With BMI Elevation

Obesity Clinical Trial

— FRISSBE  

Official title:

Fluid Resuscitation in Septic Shock Patients With BMI Elevation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04759989
• Other study ID #: Fluid resuscitation
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 25, 2022

Study information

• Verified date: August 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 25, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Actual Body Weight Dosing
30cc/kg initial bolus calculated using Actual Body Weight
• Adjusted Body Weight Dosing
30cc/kg initial bolus calculated using Adjusted Body Weight
• Ideal Body Weight Dosing
30cc/kg initial bolus calculated using Ideal Body Weight

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (6)

Arabi YM, Dara SI, Tamim HM, Rishu AH, Bouchama A, Khedr MK, Feinstein D, Parrillo JE, Wood KE, Keenan SP, Zanotti S, Martinka G, Kumar A, Kumar A; Cooperative Antimicrobial Therapy of Septic Shock (CATSS) Database Research Group. Clinical characteristics, sepsis interventions and outcomes in the obese patients with septic shock: an international multicenter cohort study. Crit Care. 2013 Apr 17;17(2):R72. doi: 10.1186/cc12680. — View Citation

Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA. Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med. 2011 Feb;39(2):259-65. doi: 10.1097/CCM.0b013e3181feeb15. — View Citation

Marik PE, Linde-Zwirble WT, Bittner EA, Sahatjian J, Hansell D. Fluid administration in severe sepsis and septic shock, patterns and outcomes: an analysis of a large national database. Intensive Care Med. 2017 May;43(5):625-632. doi: 10.1007/s00134-016-4675-y. Epub 2017 Jan 27. — View Citation

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. — View Citation

Taylor SP, Karvetski CH, Templin MA, Heffner AC, Taylor BT. Initial fluid resuscitation following adjusted body weight dosing is associated with improved mortality in obese patients with suspected septic shock. J Crit Care. 2018 Feb;43:7-12. doi: 10.1016/j.jcrc.2017.08.025. Epub 2017 Aug 15. — View Citation

Wacharasint P, Boyd JH, Russell JA, Walley KR. One size does not fit all in severe infection: obesity alters outcome, susceptibility, treatment, and inflammatory response. Crit Care. 2013 Jun 20;17(3):R122. doi: 10.1186/cc12794. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility1: fluid target	percentage of of patients with actual volume received within 10% of target fluid volume.	3 hours
Primary	Safety-ventilation	Proportion of patients requiring invasive or noninvasive mechanical ventilation	24 hours
Primary	Safety-vasopressors	proportion of patients requiring vasopressor administration	24 hours
Primary	Safety-time to hemodynamic stability	time from randomization to map >65 without use of vasopressors and no lactate >2	72 hours
Secondary	Exploratory: in-hospital all cause mortality	Proportion of patient in each group who experience death due to any cause during hospitalization up to 28 days	28 days
Secondary	Exploratory: ICU length of stay	number of consecutive midnights in ICU	28 days
Secondary	feasibility2: recruitment rate	proportion of patients enrolled out of patients screened to randomized through completion of study, an average of 1 year	study duration
Secondary	feasibility3: time to randomization	median time from screening to randomization	3 hours
Secondary	Exploratory: hospital length of stay	number of midnights spent in hospital up to 28 days	28 days