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

Sponsor

Yale University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03343041

Collaborator

(none)

Enrollment

Location

Arms

52.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 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.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 :

Jan 8, 2018

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale New Haven Hospital	New Haven	Connecticut	United States	06520

Sponsors and Collaborators

Yale University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yale University

ClinicalTrials.gov Identifier:

NCT03343041

Other Study ID Numbers:

2000021424

First Posted:

Nov 17, 2017

Last Update Posted:

Nov 26, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shock, Septic

Study Results

No Results Posted as of Nov 26, 2021