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

Study Overview
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Brief Summary
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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
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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. 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. 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. 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: Length of hospitalization Weaning from Mechanical Ventilation Development and progression of pressure ulcers Infectious diseases incidence Amount of insulin needed for glucose control Length of mechanical ventilation Readmission to Intensive Care Unit Mortality rate

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

Conditions
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Critically Ill

Intervention / Treatment
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* 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.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Patients will be receive caloric support as dictated by Hariss-Benedict Formula (Group 1) | Other: Caloric Support (Group 1)<br>* Four group 1-dose of caloric support will be calculated by Hariss-Benedict Formula measurement of Resting Energy Expenditure(REE).<br>|
| Active Comparator: Group 2<br>Patients will be receive caloric support as dictated by Indirect Calorimetry (Group 2) | Other: Caloric Support (Group 2)<br>* For group 2- dose of caloric support will be calculated by Indirect Calorimetric measurement of Resting Energy Expenditure(REE)<br>|
| Active Comparator: Group 1A<br>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. | Dietary Supplement: Protein dose of 1.1 to 1.5 grams per kilogram weight.<br>* 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.<br>|
| Active Comparator: Group 2A<br>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. | Dietary Supplement: Protein at 1.1 grams per kilogram weight.<br>* 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.<br>|
| Active Comparator: Group 3A<br>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. | Dietary Supplement: protein at a dose of 1.5 grams per kilogram weight.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Glucose Control | After one, four and eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical Ventilation