Study of Low Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock
Not Applicable
Withdrawn
- Conditions
- Bacterial Sepsis
- Registration Number
- NCT03343041
- Lead Sponsor
- Yale University
- Brief Summary
This pilot study aims to test the tolerability of low-carbohydrate enteral nutrition in patients with bacterial septic shock.
- Detailed Description
This study seeks to assess the tolerability of utilizing low-carbohydrate nutrition in patients admitted to the MICU with bacterial septic shock. Low carbohydrate feeds have been used before in the critical care setting and were well-tolerated.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients aged 18-65 admitted to the MICU with a diagnosis of severe sepsis or septic shock
- Patients with 35 > BMI > 18.5
- Patients with serum pro-calcitonin > 1 ng/mL in the first 24 hours of hospitalization
Exclusion Criteria
- Patients with chronic kidney disease as defined by glomerular filtration rate < 60 for > 6 months
- Patients with chronic liver disease as defined by radiographic or tissue evidence of cirrhosis or persistently abnormal liver function tests for > 6 months
- Patients with current malignancies
- Patients with autoimmune disease on current immunotherapy
- Patients on corticosteroids at doses of prednisone or prednisone-equivalents > 5 mg for > 6 months
- Patients with weight-reduction surgeries
- Patients with positive viral studies in the first 24 hours of admission
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Length of stay (LOS) in the ICU. discharge: average 5 days. The primary clinical outcome will be to reduce the length of stay (LOS) in the ICU. Average length of stay is 5 days.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Yale New Haven Hospital🇺🇸New Haven, Connecticut, United States