Treatment of Septic Shock by Inhibiting Autodigestion and Preserving Gut Integrity With Enteric L… (NCT02317549) | Clinical Trial Compass
TerminatedPhase 2
Treatment of Septic Shock by Inhibiting Autodigestion and Preserving Gut Integrity With Enteric LB1148
Stopped: Inability to enroll
United States8 participantsStarted 2015-04
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion 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).
✕
What they're measuring
1
Number of Days Alive Without Cardiovascular, Renal or Pulmonary Organ Support