NCT01142570

Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, prospective, randomized, comparative, double-blind controlled clinical study intended to establish 1) the optimal method of determining calorie requirements and 2) the optimal amount of protein supply in chronically ventilated patients.

Detailed description

The study will be performed in a chronic ventilation department. Enrolled patients will be randomly allocated to receive calories as dictated by: The Harriss-Benedict formula (Group 1) or Indirect Calorimetry (Group 2) After one week of admission to the hospital department and study enrollment we will review the first results of the study. After seven days of hospitalization and study enrollment patients who have not been weaned from the ventilator, will be divided into three groups. 1. Patients in the first group will receive caloric support calculated by the HARRISS BENEDICT equation and protein dose of 1.1 to 1.5 grams per kilogram weight. 2. Patients in the second group will receive caloric support as measured by indirect calorimetry and will receive protein at 1.1 grams per kilogram weight. 3. Patients in the third group will receive caloric support as measured by indirect calorimetry and will receive protein at a dose of 1.5 grams per kilogram weight. Outcome of treatment results will be performed after one ,four and eight weeks: 1. Length of hospitalization 2. Weaning from Mechanical Ventilation 3. Development and progression of pressure ulcers 4. Infectious diseases incidence 5. Amount of insulin needed for glucose control 6. Length of mechanical ventilation 7. Readmission to Intensive Care Unit 8. Mortality rate

Conditions

• Critically Ill

Interventions

Type	Name	Description
OTHER	Caloric Support (Group 1)	Four group 1-dose of caloric support will be calculated by Hariss-Benedict Formula measurement of Resting Energy Expenditure(REE).
OTHER	Caloric Support (Group 2)	For group 2- dose of caloric support will be calculated by Indirect Calorimetric measurement of Resting Energy Expenditure(REE)
DIETARY_SUPPLEMENT	Protein dose of 1.1 to 1.5 grams per kilogram weight.	Patients in the first group(Group 1A) will receive caloric support calculated by the HARRISS BENEDICT equation and protein dose of 1.1 to 1.5 grams per kilogram weight.
DIETARY_SUPPLEMENT	Protein at 1.1 grams per kilogram weight.	Patients in the second group(Group 2A) will receive caloric support as measured by indirect calorimetry and will receive protein at 1.1 grams per kilogram weight.
DIETARY_SUPPLEMENT	protein at a dose of 1.5 grams per kilogram weight.	Patients in the third group (Group 3A) will receive caloric support as measured by indirect calorimetry and will receive protein at a dose of 1.5 grams per kilogram weight.

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-09-01
• Completion: 2012-11-01
• First posted: 2010-06-11
• Last updated: 2010-10-05