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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03343041

Enrollment

Registered

2017-11-17

Start date

2018-01-08

Completion date

2022-06-30

Last updated

2021-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Sepsis

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.

Interventions

DIETARY_SUPPLEMENTlow-carbohydrate nutrition

low-carbohydrate enteral nutrition

DIETARY_SUPPLEMENTStandard enteral nutrition

standard enteral nutrition

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026