Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rabin Medical Center
- Enrollment
- 60
- Primary Endpoint
- Successful weaning from ventilation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 65 Years to 90 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 1
Patients will be receive caloric support as dictated by Hariss-Benedict Formula (Group 1)
Intervention: Caloric Support (Group 1) (Other)
Group 2
Patients will be receive caloric support as dictated by Indirect Calorimetry (Group 2)
Intervention: Caloric Support (Group 2) (Other)
Group 1A
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.
Intervention: Protein dose of 1.1 to 1.5 grams per kilogram weight. (Dietary Supplement)
Group 2A
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.
Intervention: Protein at 1.1 grams per kilogram weight. (Dietary Supplement)
Group 3A
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.
Intervention: protein at a dose of 1.5 grams per kilogram weight. (Dietary Supplement)
Outcomes
Primary Outcomes
Successful weaning from ventilation
Time Frame: At one, four and eight weeks
Spontaneous breathing
Length of hospital stay
Time Frame: At 8 weeks
Length of hospitalization, in days
Readmission to Intensive Care Unit
Time Frame: At four and eight weeks.
Readmission to Intensive Care Unit Mortality
Time Frame: At eight weeks
Length of mechanical ventilation
Time Frame: At one, four and eight weeks
Length of mechanical ventilation in days/hours
Secondary Outcomes
- 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)