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

Description

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.

Study Start Date

April 2015

Estimated Completion Date

June 2017

Interventions

  • Drug: LB1148
  • Drug: Placebo

Specialties

  • Internal Medicine: Critical Care/Hospitalist,Infectious Disease
  • Infectious Disease: Other Viral/Bacterial
  • Family Medicine: Critical Care/Emergency
  • Emergency Medicine: Infectious Disease

MeSH Terms

  • Infection
  • Shock
  • Shock, Septic

Study ID

Leading BioSciences, Inc -- LBS-SS201

Status

Unknown

Trial ID

NCT02317549

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

260

Sponsor

Leading BioSciences, Inc

Inclusion Criteria

    1. First episode of sepsis of peritoneal/abdominal, soft tissue, blood, or community acquired lung origin 2. Antimicrobial therapy for suspected infection 3. Hypotension requiring vasopressor support despite receiving at least 30 mL/kg crystalloid or colloid equivalent within a time period of 4 hr prior to and up to 4 hr after the start of vasopressors 4. Hypotension requiring vasopressor support (for more than 4 hr and at randomization) 5. Serum lactate level ?4.0 mmol/L 6. Patient or surrogate must be willing and able to comply with all required study procedures per protocol Inclusion Criteria for Randomization: 7. A serum lactate ?3.0 mmol/L at least 4 hr after the first (Inclusion Criteria #5). This subsequent serum lactate measurements must must not have improved by greater than 50% from the first

Exclusion Criteria

    1. Age ?76 years 2. Time elapsed since onset of shock is ?24 hr 3. Septic shock episode is the second or greater episode in current hospitalization patients transferred from another healthcare facility that are still within the first 24 hr of the first episode of shock are eligible 4. Healthcare-acquired lung infection 5. Genitourinary infections 6. Inability to achieve and maintain a systolic blood pressure (SBP) of 90 mmHg or a mean arterial pressure (MAP) of at least 60 mmHg despite vasopressor support and fluid resuscitation. BP must be maintained more than 70% of the time 7. Serum lactate level >12.0 mmol/L at any point during the screening period 8. Serum lactate levels improved by greater than 50% at the subsequent assessment, but are still ?3.0 mmol/L. If a patient has more than 2 serum lactate measurements, an interim measurement >50% clearance does not exclude the patient, if the patient still has 2 measurements that are separated by 4 hr and the subsequent of which has not improved by greater than 50%, nor is are still ?3.0 mmol/L 9. Highest SOFA score during screening period < 9. (Each individual organ component sub-score is calculated from the highest (worst) score obtained for that organ during the screening period, up until randomization) 10. Highest SOFA score during screening period >18 11. A lack of commitment to aggressive source control 12. Failure to voluntarily sign an informed consent form 13. Ineligible for feeding tube placement 14. Chronic renal insufficiency requiring hemodialysis 15. Chronic pulmonary dysfunction requiring mechanical ventilation 16. Not expected to survive >28 days due to a preexisting condition.
  • HIV-positive patients whose most recent CD4 count was ?50/mm3
  • Neutrophils < 1000/mm3 unless due to sepsis
  • Chest compressions as part of CPR during this hospitalization without neurologic recovery
  • Poorly controlled neoplasm
  • End-stage lung disease
  • End-stage liver disease (Child-Pugh Class C (score >10), evidence of portal hypertension or esophageal varices)
  • Severe congestive heart failure (New York Heart Association [NYHA] Class IV or pre-sepsis ejection fraction [EF] < 30%)
  • Organ transplant (including, but not limited to bone marrow, heart, lung, liver, pancreas, or small bowel transplantation) 17. Contraindications to test article:
  • Sensitivity to TXA
  • Recent craniotomy
  • Active cerebrovascular bleed
  • Active thromboembolic disease (eg deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome 18. Exclusion for other reasons:
  • Presence of 3rd degree burns involving >20% body surface area in the 7 days prior to study entry
  • Inability to take the study medication (i.e. complete small bowel obstruction)
  • Any condition that in the opinion of the investigator would preclude the subject from being an appropriate candidate for the study 19. Received investigational therapy within 4 weeks prior to Screening 20. Positive urine or serum pregnancy test, or lactating females who insist on breast feeding within 5 days of the last dose of study drug

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (26)

Study Location Distance Name Phone Email
Lahey Hospital and Medical Center - Burlington, Massachusetts 11.0 miles Timothy N Liesching MD None None
Baystate Medical Center - Springfield, Massachusetts 78.9 miles Jay S Steingrub MD None None
New York Methodist Hospital - Brooklyn, New York 190.2 miles Amisha Parekh MD None None
Cooper University Hospital - Camden, New Jersey 268.3 miles Richard P Dellinger MD None None
University of Virginia Health System - Charlottesville, Virginia 493.4 miles Kyle Enfield MD None None
Henry Ford Hospital - Detroit, Michigan 612.3 miles Emanuel P Rivers None None
UNC Chapel Hill - Chapel Hill, North Carolina 616.4 miles Shannon Carson MD None None
Mercy St Vincent Medical Center Clinical Research Offices - Toledo, Ohio 640.8 miles Luis E JaureguiPeredo MD None None
University of Michigan Health Center - Ann Arbor, Michigan 645.2 miles Robert C Hyzy MD None None
Wake Forest Baptist Health - Winston-Salem, North Carolina 659.2 miles Daniel C Files MD None None
ARH Regional Medical Center - Hazard, Kentucky 733.1 miles Firas A Koura MD None None
University of Louisville Hospital Laboratory - Louisville, Kentucky 823.2 miles Nicholas A Nash MD None None
Froedtert Hospital and Medial College of Wisconsin - Milwaukee, Wisconsin 862.1 miles Jayshil Patel MD None None
Vanderbilt University Medical Center - Nashville, Tennessee 944.2 miles Todd W Rice MD None None
OSF Saint Francis Medical Center - Peoria, Illinois 963.6 miles William P Tillis MD None None
Barnes Jewish Hospital - St. Louis, Missouri 1,039.5 miles William Symons MD None None
University of Iowa - Iowa City, Iowa 1,050.4 miles Kevin Doerschug MD None None
Mayo Clinic Labs Rochester Campus - Rochester, Minnesota 1,083.1 miles John Park MD None None
Providence Hospital - Mobile, Alabama 1,244.2 miles Allen F Seibert IV MD None None
University of Kansas Medical Center - Kansas City, Kansas 1,251.3 miles Steven Simpson MD None None
OU Medical Center - Oklahoma City, Oklahoma 1,493.6 miles Karen Allen MD None None
Ben Taub Hospital - Houston, Texas 1,609.9 miles Kalpalatha Guntupali MD None None
St Patrick Hospital - Missoula, Montana 2,111.5 miles William Surber MD None None
Community Regional Medical Center Fresno - Fresno, California 2,593.5 miles Wee Kiat David Lee MD None None
Long Beach Memorial Medical Center - LongBeach, California 2,600.0 miles Maged Tanios MD None None
UC Davis Medical Center - Sacramento, California 2,628.4 miles Timothy Albertson MD None None

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