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

NCT03343041 | Withdrawn

• 1 other identifier: 2000021424
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bacterial Sepsis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

low carbohydrate nutrition

ACTIVE COMPARATOR

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

standard enteral nutrition

ACTIVE COMPARATOR

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

Interventions

low-carbohydrate nutrition DIETARY_SUPPLEMENT

low-carbohydrate enteral nutrition

low carbohydrate nutrition

Standard enteral nutrition DIETARY_SUPPLEMENT

standard enteral nutrition

standard enteral nutrition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Study Officials

• Andrew Wang, MD PhD

  Yale School of Medicine Department of Rheumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 17, 2017
• Study Start: January 8, 2018
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 26, 2021

Record last verified: 2021-11

Locations

US (1)