Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study (ANUS1014)

Eastern Virginia Medical School (EVMS)

Status and phase: Terminated; Phase 4

Conditions: Subarachnoid Hemorrhage; Intracranial Hemorrhage; Subdural Hematoma; Ischemic Strokes

Treatments: Dietary Supplement: Jevity - Control Diet; Dietary Supplement: Glycerna

Study type: Interventional

Funder types: Other

Identifiers

NCT01463878

ANUS1014

Details and patient eligibility

About

Primary Objective:

To determine the effects of a diabetes specific enteral formula compared to a standard formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose and glycemic variability in a homogenous group of critically ill patients in a neurological ICU. Blood glucose will be recorded every minute using a continuous blood glucose monitor. The primary end points will be the difference between the mean blood glucose levels and the glucose variability between the control and intervention groups for the time period that the patient is in the ICU and receiving tube feeds and for up to a maximum of 14 days.

Secondary Objectives:

To determine the effects of the diabetes specific versus standard tube feeds on the change in muscle thickness and volume measured by 2-dimensional ultrasound imaging during the patients ICU stay.

Enrollment: 14 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged between 18 and 89 years old
• Patients with critical illness including ischemic or hemorrhagic stroke, epidural/subdural bleeds and subarachnoid hemorrhage
• Patients who are expected to stay in the ICU for at least 5 days
• Hyperglycemia is not an inclusion criteria

Exclusion criteria

• Patients who have received or will be treated with systemic corticosteroids.
• Patients who will be receiving high doses of propofol (>40 cc/hr)
• Patients with type 1 Diabetes
• Patients with sepsis or acute trauma
• Patients with an expected stay in the ICU of less than 4 days
• Patients who are unable to receive enteral nutrition or who have medical conditions precluding nutrition by the enteral route including allergies to formula components
• Pregnant and lactating patients
• Patients with prior history of gastroparesis
• Patients with acute kidney failure (creatinine > 2.5mg/dl)
• Patients with acute liver failure (bilirubin > 2.0 mg/dl)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

14 participants in 2 patient groups

Glycerna

Experimental group

Description:

Diabetic specific formula. The volume /rate of glycerna will be determined by the dietician according to standard formula.

Treatment:

Dietary Supplement: Glycerna

Control - Jevity

Active Comparator group

Description:

The control arm of the study. Patients to receive Jevity. The volume /rate of Jevity will be determined by the dietician according to standard formula.

Treatment:

Dietary Supplement: Jevity - Control Diet