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

Yale University

Status: Withdrawn

Conditions: Bacterial Sepsis

Treatments: Dietary Supplement: low-carbohydrate nutrition; Dietary Supplement: Standard enteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT03343041

2000021424

Details and patient eligibility

About

This pilot study aims to test the tolerability of low-carbohydrate enteral nutrition in patients with bacterial septic shock.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 18-65 admitted to the MICU with a diagnosis of severe sepsis or septic shock
2. Patients with 35 > BMI > 18.5
3. Patients with serum pro-calcitonin > 1 ng/mL in the first 24 hours of hospitalization

Exclusion criteria

1. Patients with chronic kidney disease as defined by glomerular filtration rate < 60 for > 6 months
2. Patients with chronic liver disease as defined by radiographic or tissue evidence of cirrhosis or persistently abnormal liver function tests for > 6 months
3. Patients with current malignancies
4. Patients with autoimmune disease on current immunotherapy
5. Patients on corticosteroids at doses of prednisone or prednisone-equivalents > 5 mg for > 6 months
6. Patients with weight-reduction surgeries
7. Patients with positive viral studies in the first 24 hours of admission

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

low carbohydrate nutrition

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: low-carbohydrate nutrition

standard enteral nutrition

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Standard enteral nutrition