SepsisFRISSBENCT04759989
Fluid Resuscitation in Septic Shock Patients With BMI Elevation
A study testing Actual Body Weight Dosing, Adjusted Body Weight Dosing and Ideal Body Weight Dosing in people with Sepsis and Septic Shock, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To explore the safety and feasibility of alternative fluid resuscitation strategies in obese patients with septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Obesity
- What is being tested?
- Actual Body Weight Dosing, Adjusted Body Weight Dosing and Ideal Body Weight Dosing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 25 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- BMI > 30
- suspected infection, and either:
- hypotension (a systolic blood pressure < 90mmHg) or
- blood lactate concentration > 4mmol/L
Who cannot join
- Pregnant
- Primary diagnosis of acute cerebral vascular event
- Acute coronary syndrome
- Acute pulmonary edema
- Status asthmaticus
- Major cardiac arrhythmia
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28203
About this study
To explore the safety and feasibility of alternative fluid resuscitation strategies in obese patients with septic shock.
Read the 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).
- Conditions
- Sepsis, Septic Shock, Obesity
- Being tested
- Actual Body Weight Dosing, Adjusted Body Weight Dosing, Ideal Body Weight Dosing
- Medical subject headings
- Sepsis, Shock, Septic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actual Body Weight DosingProcedure or surgery
30cc/kg initial bolus calculated using Actual Body Weight
Adjusted Body Weight DosingProcedure or surgery
30cc/kg initial bolus calculated using Adjusted Body Weight
Ideal Body Weight DosingProcedure or surgery
30cc/kg initial bolus calculated using Ideal Body Weight
| Study group | Role | What they receive |
|---|---|---|
| 30cc/kg ideal body weight (IBW) | Active comparator | 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) Receives: Procedure: Ideal Body Weight Dosing |
| 30cc/kg adjusted body weight (AdjBW) | Active comparator | 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). Receives: Procedure: Adjusted Body Weight Dosing |
| 30cc/kg actual body weight (ABW) | Active comparator | 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 Receives: Procedure: Actual Body Weight Dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility1: fluid target
percentage of of patients with actual volume received within 10% of target fluid volume.
Measured: 3 hours
Safety-ventilation
Proportion of patients requiring invasive or noninvasive mechanical ventilation
Measured: 24 hours
Safety-vasopressors
proportion of patients requiring vasopressor administration
Measured: 24 hours
Safety-time to hemodynamic stability
time from randomization to map >65 without use of vasopressors and no lactate >2
Measured: 72 hours
Secondary outcomes (5)
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
Measured: 28 days
Exploratory: ICU length of stay
number of consecutive midnights in ICU
Measured: 28 days
feasibility2: recruitment rate
proportion of patients enrolled out of patients screened to randomized through completion of study, an average of 1 year
Measured: study duration
feasibility3: time to randomization
median time from screening to randomization
Measured: 3 hours
Exploratory: hospital length of stay
number of midnights spent in hospital up to 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Jun 2021
- Primary completion25 Apr 2022
- Study completion25 May 2022
Why it stopped: The study is being closed due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brice Taylor, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759989
- Sponsor's protocol ID
- Fluid resuscitation
- Acronym
- FRISSBE
- Status last verified
- Aug 2022
- First submitted
- 10 Feb 2021
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28098591Wacharasint 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.
PubMed 23786836Arabi 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.
PubMed 23594407Boyd 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.
PubMed 20975548Marik 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.
PubMed 28130687Taylor 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.
PubMed 28823951
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Resuscitation in Septic Shock Patients With BMI Elevation
- ClinicalTrials.gov ID
- NCT04759989
- Acronym / sponsor ID
- FRISSBE / Fluid resuscitation
- Conditions
- Sepsis, Septic Shock, Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is being closed due to low enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 30cc/kg ideal body weight (IBW) | Active comparator | Procedure: Ideal Body Weight Dosing30cc/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) |
| 30cc/kg adjusted body weight (AdjBW) | Active comparator | Procedure: Adjusted Body Weight Dosing30cc/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). |
| 30cc/kg actual body weight (ABW) | Active comparator | Procedure: Actual Body Weight Dosing30cc/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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- BMI > 30
- suspected infection, and either:
Key exclusion criteria (14 listed)
- Pregnant
- Primary diagnosis of acute cerebral vascular event
- Acute coronary syndrome
- Acute pulmonary edema
- Status asthmaticus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actual Body Weight Dosing30cc/kg initial bolus calculated using Actual Body Weight | Procedure or surgery | 30cc/kg actual body weight (ABW) |
| Adjusted Body Weight Dosing30cc/kg initial bolus calculated using Adjusted Body Weight | Procedure or surgery | 30cc/kg adjusted body weight (AdjBW) |
| Ideal Body Weight Dosing30cc/kg initial bolus calculated using Ideal Body Weight | Procedure or surgery | 30cc/kg ideal body weight (IBW) |
Primary outcome
Feasibility1: fluid target
Time frame: 3 hours
percentage of of patients with actual volume received within 10% of target fluid volume.
Safety-ventilation
Time frame: 24 hours
Proportion of patients requiring invasive or noninvasive mechanical ventilation
Safety-vasopressors
Time frame: 24 hours
proportion of patients requiring vasopressor administration
Safety-time to hemodynamic stability
Time frame: 72 hours
time from randomization to map >65 without use of vasopressors and no lactate >2
5 secondary outcomes
Exploratory: in-hospital all cause mortality
Time frame: 28 days
Exploratory: ICU length of stay
Time frame: 28 days
feasibility2: recruitment rate
Time frame: study duration
feasibility3: time to randomization
Time frame: 3 hours
Exploratory: hospital length of stay
Time frame: 28 days
Results and safety
The study was stopped early (reason given: The study is being closed due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Background: PubMed 28098591Rhodes 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.
- Background: PubMed 23786836Wacharasint 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.
- Background: PubMed 23594407Arabi 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.
- Background: PubMed 20975548Boyd 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.
- Background: PubMed 28130687Marik 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.
- Background: PubMed 28823951Taylor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brice Taylor, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actual Body Weight Dosing, Adjusted Body Weight Dosing and Ideal Body Weight Dosing in people with Sepsis and Septic Shock, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study is being closed due to low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility1: fluid target (time frame: 3 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04759989, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.