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

Not Applicable

Withdrawn

• Conditions: Bacterial Sepsis
• Interventions: Dietary Supplement: low-carbohydrate nutrition; Dietary Supplement: Standard enteral nutrition

• 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.

Study Timeline

• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-11-10
• Study First Posted: 2017-11-17
• Study Start: 2018-01-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-26
• Primary Completion: 2022-01
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low carbohydrate nutrition	low-carbohydrate nutrition	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.
standard enteral nutrition	Standard enteral nutrition	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

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.

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States