Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study

NCT01463878 | Terminated Phase 4 Results

• 1 other identifier: ANUS1014
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Glycemic Variability

  The patients blood glucose levels will be monitored with a continuous blood glucose monitor which records the calibrated blood glucose level every minute. The mean blood glucose over the patients entire ICU stay (up to 14 days) as well as the mathematical variation (fluctuation) in blood glucose levels will be calculated. The degree of glycemic variation will be assessed by a number of mathematical formula, including mean amplitude of glycemic excursions (MAGE). These parameters will be compared between the control and intervention groups.

  Entire ICU stay. Up to 14 days in the ICU (average about 7 days)

Secondary Outcomes (1)

• Quadriceps Muscle Volume

  First versus last measurment in ICU. Up to 14 days (average 7 days)

Study Arms (2)

Glycerna

EXPERIMENTAL

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

Dietary Supplement: Glycerna

Control - Jevity

ACTIVE COMPARATOR

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.

Dietary Supplement: Jevity - Control Diet

Interventions

Glycerna DIETARY_SUPPLEMENT

Diabetes specific formula

Glycerna

Jevity - Control Diet DIETARY_SUPPLEMENT

Control Diet

Control - Jevity

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Study Sites (1)

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Intracranial Hemorrhages; Ischemic Stroke; Hematoma, Subdural

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Intracranial Hemorrhage, Traumatic; Craniocerebral Trauma; Trauma, Nervous System; Hematoma; Wounds and Injuries

Results Point of Contact

• Title: Dr Paul Marik
• Organization: Eastern Virginia Medical School

marikpe@evms.edu

757-446-8910

Study Officials

• Paul e Marik, MD

  EVMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Pulmnary and Critical Care Medicine

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: November 2, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 5, 2012
• Results First Posted: September 28, 2012

Record last verified: 2012-10

Locations

US (1)