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

November 16, 2021 updated by: Yale University

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: low carbohydrate nutrition

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
low-carbohydrate enteral nutrition
Active Comparator: standard enteral nutrition

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
standard enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
discharge: average 5 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Andrew Wang, MD PhD, Yale School of Medicine Department of Rheumatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

November 10, 2017

First Submitted That Met QC Criteria

November 10, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000021424

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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