Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study

Subarachnoid Hemorrhage Clinical Trial

— ANUS1014  

Official title:

Enteral Nutrition and Glycemic Variability NICU Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01463878
• Other study ID #: ANUS1014
• Status: Terminated
• Phase: Phase 4
• First received: October 24, 2011
• Last updated: October 3, 2012
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: Eastern Virginia Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhage
• Intracranial Hemorrhages
• Ischemic Strokes
• Subarachnoid Hemorrhage
• Subdural Hematoma

Intervention

Dietary Supplement:
• Glycerna
Diabetes specific formula
• Jevity - Control Diet
Control Diet

Locations

Country	Name	City	State
United States	Sentara Norfolk General Hospital	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Virginia Medical School

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Quadriceps Muscle Volume	The quadriceps muscle volume will be estimated by 2-dimensional ultrasound imaging at enrollment and at the end of the study period (when the patient is being transferred from the ICU or no longer receiving tube feeds). The change in muscle mass during the ICU stay will be compared between the control and intervention groups.	First versus last measurment in ICU. Up to 14 days (average 7 days)	No