Study of Low Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock

Study Overview
=================
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.

Official Title
-----------------
Pilot Study of Low-Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock

Conditions
-----------------
Bacterial Sepsis

Intervention / Treatment
-----------------
* Dietary Supplement: low-carbohydrate nutrition
* Dietary Supplement: Standard enteral nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The ultimate goal is to perform a prospective, single-center, double-blinded, parallel group, randomized, controlled trial on the safety and efficacy of low-carbohydrate enteral nutrition in adult patients admitted to the MICU with bacterial septic shock.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low carbohydrate nutrition<br>We will use a low-carbohydrate nutrition (LCN) formulated by the MICU registered dietitian and pharmacy staff, who routinely prepare enteral and parenteral nutrition which will provide: 5% carb, 41% protein, 54% lipid. | Dietary Supplement: low-carbohydrate nutrition<br>* low-carbohydrate enteral nutrition<br>|
| Active Comparator: standard enteral nutrition<br>The standard enteral nutrition (SEN) and per cent contribution of carbohydrates used in the Yale MICU is as follows: Jevity 1.2 56% carb, 29.5% lipid, 18.5% protein Diabetisource 33% carb, 44% lipid, 20% protein Promote 55% carb, 25% lipid, 25% protein Vital AF 37% carb, 40% lipid, 25% protein Peptamin Intense 29% carb, 34% lipid, 37% protein Osmolite 1.5 54% carb, 29.5% lipid, 16.5% protein | Dietary Supplement: Standard enteral nutrition<br>* standard enteral nutrition<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay (LOS) in the ICU. | The primary clinical outcome will be to reduce the length of stay (LOS) in the ICU. Average length of stay is 5 days. | discharge: average 5 days. |