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

Bacterial Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03343041
• Other study ID #: 2000021424
• Status: Withdrawn
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: June 2022

Study information

• Verified date: November 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Sepsis
• Shock, Septic

Intervention

Dietary Supplement:
• low-carbohydrate nutrition
low-carbohydrate enteral nutrition
• Standard enteral nutrition
standard enteral nutrition

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.