The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU

Nestlé

Status

Completed

Conditions

Critically Ill Mechanically Ventilated Subjects

Treatments

Other: Replete

Other: Peptamen Bariatric

Study type

Interventional

Funder types

Industry

Identifiers

NCT02337556

13.23.CLI

Details and patient eligibility

About

To compare the nutritional effect on blood glucose of two commercially available enteral diets in overweight or obese patients in the Intensive Care Unit.

Enrollment

106 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

New admit to the ICU and expected to remain in ICU 5 days
Ventilator dependent up to 48 hours prior to admission to the study
Requiring tube feeding enteral nutrition (EN) 5 days
Expected to receive 50% of caloric needs within 72 hours
Body Mass Index 26-45

Exclusion criteria

Trauma patients
Major surgery in past 30 days or planned for next 7 days
Diabetes mellitus (DM) type 1
Admitted with diagnosis of diabetic ketoacidosis as primary diagnosis
Pregnant or lactating
Non-functioning GI tract
Use of parenteral nutrition in past 30 days
Admitted with burns > 20% body surface area
Traumatic brain injury
Hemodynamic instability that prevents delivery of EN > 24hr
Unable to access GI tract for feeding via tube, unable to receive EN
Other contraindication to tube feeding
Any other condition that would not allow patient to complete the study protocol
Use of enteral formula at enrollment that cannot be changed to the investigational product