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

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ClinicalTrials.gov Identifier: NCT03343041
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

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

Condition or disease Intervention/treatment Phase
Bacterial Sepsis Dietary Supplement: low-carbohydrate nutrition Dietary Supplement: Standard enteral nutrition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pilot Study of Low-Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343041


Contacts
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Contact: Andrew Wang, MD PhD 214-636-6420 andrew.wang@yale.edu
Contact: Margaret Pisiani, MD 203-572-4013 margaret.pisani@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Andrew Wang, MD PhD         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Andrew Wang, MD PhD Yale School of Medicine Department of Rheumatology

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03343041     History of Changes
Other Study ID Numbers: 2000021424
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock