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

NCT ID: NCT03343041

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2022-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Bacterial Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

low-carbohydrate nutrition

Intervention Type DIETARY_SUPPLEMENT

low-carbohydrate enteral nutrition

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

Group Type ACTIVE_COMPARATOR

Standard enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

standard enteral nutrition

Interventions

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low-carbohydrate nutrition

low-carbohydrate enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Standard enteral nutrition

standard enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Wang, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Yale School of Medicine Department of Rheumatology

Locations

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Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2000021424

Identifier Type: -

Identifier Source: org_study_id