Back to resultsStudy of Low Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock
Primary Purpose
Bacterial Sepsis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
low-carbohydrate nutrition
Standard enteral nutrition
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Sepsis
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
Sites / Locations
- Yale New Haven Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
low carbohydrate nutrition
standard enteral nutrition
Arm 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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03343041
Brief Title
Study of Low Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock
Official Title
Pilot Study of Low-Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Covid and lack of resources
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low carbohydrate nutrition
Arm Type
Active Comparator
Arm 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.
Arm Title
standard enteral nutrition
Arm Type
Active Comparator
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
low-carbohydrate nutrition
Intervention Description
low-carbohydrate enteral nutrition
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard enteral nutrition
Intervention Description
standard enteral nutrition
Primary Outcome Measure Information:
Title
Length of stay (LOS) in the ICU.
Description
The primary clinical outcome will be to reduce the length of stay (LOS) in the ICU. Average length of stay is 5 days.
Time Frame
discharge: average 5 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Wang, MD PhD
Organizational Affiliation
Yale School of Medicine Department of Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Low Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock
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