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

Not Applicable

• Conditions: Critically Ill
• Interventions: Other: Caloric Support (Group 1); Other: Caloric Support (Group 2); Dietary Supplement: Protein dose of 1.1 to 1.5 grams per kilogram weight.; Dietary Supplement: Protein at 1.1 grams per kilogram weight.; Dietary Supplement: protein at a dose of 1.5 grams per kilogram weight.

• Registration Number: NCT01142570
• Lead Sponsor: Rabin Medical Center

Brief 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

Study Timeline

• Status Verified: 2010-01
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Study Start: 2010-09
• Last Update Submitted: 2010-10-03
• Last Update Posted: 2010-10-05
• Primary Completion: 2012-09
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Chronically Mechanical Ventilated Patients (more than 21 days of Mechanical Ventilation) by tracheostomy,
• Between ages 65-90

Exclusion Criteria

• Patient over age 90 and younger the age of 65
• PH level less than 7.3 due to metabolic causes.
• A patient with blood albumin level less than 2.2 g / dl

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Caloric Support (Group 1)	Patients will be receive caloric support as dictated by Hariss-Benedict Formula (Group 1)
Group 2	Caloric Support (Group 2)	Patients will be receive caloric support as dictated by Indirect Calorimetry (Group 2)
Group 1A	Protein dose of 1.1 to 1.5 grams per kilogram weight.	After seven days of hospitalization and study enrollment patients who have not been weaned from ventilator, will be divided into three groups. Patients in the first(Group 1A)group will receive caloric support calculated by the HARISS BENEDICT equation and protein dose of 1.1 to 1.5 grams per kilogram weight.
Group 2A	Protein at 1.1 grams per kilogram weight.	After seven days of hospitalization and study enrollment patients who have not been weaned from ventilator, will be divided into three groups. 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.
Group 3A	protein at a dose of 1.5 grams per kilogram weight.	After seven days of hospitalization and study enrollment patients who have not been weaned from ventilator, will be divided into three groups. 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.

Primary Outcome Measures

Name	Time	Method
Successful weaning from ventilation	At one, four and eight weeks	Spontaneous breathing
Length of hospital stay	At 8 weeks	Length of hospitalization, in days
Readmission to Intensive Care Unit	At four and eight weeks.
Readmission to Intensive Care Unit Mortality	At eight weeks
Length of mechanical ventilation	At one, four and eight weeks	Length of mechanical ventilation in days/hours

Secondary Outcome Measures

Name	Time	Method
Infectious diseases incidence	At one, four and eight weeks
Development and progression of pressure ulcers	At one, four and eight weeks
Checked daily insulin intake among different groups of patients	After one, four and eight weeks	Glucose Control