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Clinical Trials/NCT03343041
NCT03343041
Withdrawn
Not Applicable

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

Yale University1 site in 1 countryJanuary 8, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bacterial Sepsis
Sponsor
Yale University
Locations
1
Primary Endpoint
Length of stay (LOS) in the ICU.
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 8, 2018
End Date
June 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Length of stay (LOS) in the ICU.

Time Frame: 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.

Study Sites (1)

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