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

Critically Ill Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

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

Clinical Trial Details
NCT number NCT01142570
Study type Interventional
Source Rabin Medical Center
Contact
Status Active, not recruiting
Phase N/A
Start date September 2010
Completion date November 2012
View Details
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