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

August 10, 2022 updated by: Wake Forest University Health Sciences
To explore the safety and feasibility of alternative fluid resuscitation strategies in obese patients with septic shock.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility1: fluid target
Time Frame: 3 hours
percentage of of patients with actual volume received within 10% of target fluid volume.
3 hours
Safety-ventilation
Time Frame: 24 hours
Proportion of patients requiring invasive or noninvasive mechanical ventilation
24 hours
Safety-vasopressors
Time Frame: 24 hours
proportion of patients requiring vasopressor administration
24 hours
Safety-time to hemodynamic stability
Time Frame: 72 hours
time from randomization to map >65 without use of vasopressors and no lactate >2
72 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
28 days
Exploratory: ICU length of stay
Time Frame: 28 days
number of consecutive midnights in ICU
28 days
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
study duration
feasibility3: time to randomization
Time Frame: 3 hours
median time from screening to randomization
3 hours
Exploratory: hospital length of stay
Time Frame: 28 days
number of midnights spent in hospital up to 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brice Taylor, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Fluid resuscitation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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