Treatment of Septic Shock by Inhibiting Autodigestion and Preserving Gut Integrity With Enteric LB1148

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Septic Shock

In brief

Septic shock is a potentially life-threatening condition that can result in multi-organ dysfunction syndrome (MODS) and mortality. LB1148 was formulated to preserve gut integrity during physiological shock and ameliorate the subsequent autodigestion leading to MODS and mortality. The purpose of this study in septic shock patients is to determine if enteral administration of LB1148 will increase the number of days alive without cardiovascular, pulmonary or renal replacement therapy through Day 28.

Key facts

Study ID: NCT02317549
Run by: Leading BioSciences, Inc
People needed: 8
Starts: 2015-04-01
Expected to finish: 2016-03-01
Last updated by the study team: 2020-06-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

First episode (during the current hospitalization) of documented or suspected sepsis of peritoneum/abdomen, soft tissue, blood, or non-hospital acquired lung origin.
Must be receiving antimicrobial therapy for documented or suspected infection.
Must have septic shock requiring vasopressors despite adequate fluid resuscitation of 30 mL/kg crystalloid or colloid equivalent, for either an SBP ≤90 mmHg or a MAP ≤65 mmHg (i.e. must have been unable to maintain adequate blood pressure despite adequate fluid resuscitation without the use of vasopressors). Note: 30 mL/kg crystalloid is equivalent to 15 mL/kg colloids.
Must have a requirement for vasopressor support after adequate fluid resuscitation, and, at randomization, must require a minimum dose of at least 1 of the following vasopressors:
Norepinephrine ≥5 µg/min;
Dopamine ≥10 µg/kg/min;
Phenylephrine ≥25 µg/min;
Epinephrine ≥5 µg/min, or
Vasopressin ≥0.03 units/min.

You may not qualify if…

Patients will not be eligible for participation in the study if they meet ANY of the following criteria:
Age <18 or age ≥76 years.
Time elapsed since onset of shock is >24 hours. Onset of shock is defined as the first administration of a vasopressor given by continuous infusion (i.e. not a single bolus of norepinephrine, phenylephrine, or ephedrine).
Septic shock episode is the second or greater episode in current hospitalization.
Note: patients transferred from another healthcare facility that are still within the first 24 hours of the first episode of shock are eligible.
Have hospital acquired pneumonia.
Have genitourinary infections as the cause of septic shock.
Unable to maintain a minimum MAP of 60 mmHg despite the presence of vasopressors and IV fluids.
Note: brief transient BPs below 60 mmHg are not disqualifying.
Have a serum lactate measurement <2.5 mmol/L after adequate fluid resuscitation (refer to Inclusion Criteria #3).
Not expected to survive for at least 28 days due to a preexisting, non-shock related medical condition.
Highest total SOFA score (known to staff at the time of randomization) during the screening period <6.
Note: each individual organ component sub-score is calculated from the highest (worst) score obtained for that organ during the screening period, up until randomization.
Highest total SOFA score (known to staff at the time of randomization) during the screening period >18.
Note: each individual organ component sub-score is calculated from the highest (worst) score obtained for that organ during the screening period.
Lack of commitment to aggressive source control of infection.
The patient or patient's surrogate fails to voluntarily sign an informed consent form (ICF).
Ineligible for feeding tube placement.
Chronic renal insufficiency requiring hemodialysis not associated with the current episode of sepsis.
Chronic pulmonary dysfunction requiring mechanical ventilation unrelated to the current episode of sepsis.
Undergoing active radiation or cytotoxic chemotherapy treatment for uncontrolled malignancy.
Note: hormonal and surgical therapies are permitted.
Presence of third degree burns involving >20% body surface area in the 7 days prior to study entry.
Known inability to take the study medication (i.e. complete small bowel obstruction).
Has acute meningitis.

Where it is running

Providence Hospital — Mobile, Alabama, United States
Community Regional Medical Center, Fresno — Fresno, California, United States
Long Beach Memorial Medical Center — Long Beach, California, United States
UC Davis Medical Center — Sacramento, California, United States
OSF Saint Francis Medical Center — Peoria, Illinois, United States
University of Iowa — Iowa City, Iowa, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
ARH Regional Medical Center — Hazard, Kentucky, United States
University of Louisville Hospital Laboratory — Louisville, Kentucky, United States
Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
Baystate Medical Center — Springfield, Massachusetts, United States
University of Michigan Health Center — Ann Arbor, Michigan, United States
Henry Ford Hospital — Detroit, Michigan, United States
Mayo Clinic Labs - Rochester Campus — Rochester, Minnesota, United States
Barnes Jewish Hospital — St Louis, Missouri, United States
St. Patrick Hospital — Missoula, Montana, United States
Cooper University Hospital — Camden, New Jersey, United States
New York Methodist Hospital — Brooklyn, New York, United States
UNC Chapel Hill — Chapel Hill, North Carolina, United States
Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
Mercy St. Vincent Medical Center, Clinical Research Offices — Toledo, Ohio, United States
OU Medical Center — Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
Ben Taub Hospital — Houston, Texas, United States
University of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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