Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study

NCT ID: NCT01463878

Last Updated: 2012-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-06-30

Brief Summary

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.

Conditions

Subarachnoid Hemorrhage; Intracranial Hemorrhage; Ischemic Strokes; Subdural Hematoma

Keywords

glycemic control; glycemic variability; mean blood glucose level

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Glycerna

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

Group Type: EXPERIMENTAL

Glycerna

Intervention Type: DIETARY_SUPPLEMENT

Diabetes specific formula

Control - Jevity

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.

Group Type: ACTIVE_COMPARATOR

Jevity - Control Diet

Intervention Type: DIETARY_SUPPLEMENT

Control Diet

Interventions

Glycerna

Diabetes specific formula

Intervention Type: DIETARY_SUPPLEMENT

Jevity - Control Diet

Control Diet

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Virginia Medical School

OTHER

Sponsor Role: lead

Responsible Party

Paul Marik

Chief of Pulmnary and Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul e Marik, MD

Role: PRINCIPAL_INVESTIGATOR

EVMS

Locations

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

ANUS1014

Identifier Type: -

Identifier Source: org_study_id