Status:
COMPLETED
Inulin for Infections in the Intensive Care Unit
Lead Sponsor:
Columbia University
Conditions:
Antibiotic Resistant Infection
Nosocomial Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Normal gut bacteria prevent colonization and subsequent infection with MDR organisms (MDROs) through competition for resources and other mechanisms. During critical illness, this function of the micro...
Detailed Description
The proposed trial hypothesizes that inulin maintains short-chain fatty acid (SCFA)-producing colonic anaerobes and that these bacteria are protective against multi-drug resistant organism (MDRO) colo...
Eligibility Criteria
Inclusion
- Hospitalized in an eligible medical ICU
- Age ≥ 18 years old at the time of hospitalization
- With sepsis as defined by the Sepsis-3 (2016) consensus as a known or suspected infection with a sequential organ failure assessment (SOFA) score of ≥2 points above baseline
- Received broad-spectrum antibiotics within the last 24 hours or ordered and pending administration
- Able to complete enrollment within 4 hours of ICU admission for administration of the intervention within 6 hours of ICU admission
Exclusion
- Inability to receive oral or enteric fluids
- Inulin allergy
- Hyponatremia (serum sodium ≤128 mEq/L)
- Immunosuppression, defined as history of solid organ transplant or as receipt of ablative chemotherapy, steroids at the equivalent of ≥5 mg/day prednisone, antimetabolites, anti-tumor necrosis factor (TNF) α agents, calcineurin inhibitors, or mycophenolate
- Surgery involving the intestinal lumen within 30 days or known intestinal strictures
- Do Not Resuscitate (DNR) or Do Not Intubate (DNI) status, or "no escalation of care" orders
- Lack capacity for consent and no appropriate Legally Authorized Representative (LAR)
Key Trial Info
Start Date :
October 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2024
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT03865706
Start Date
October 14 2019
End Date
July 23 2024
Last Update
June 19 2025
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10023