Critically Ill
Conditions
Keywords
Mechanical Ventilation
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
Interventions
OTHERCaloric Support (Group 1)
Four group 1-dose of caloric support will be calculated by Hariss-Benedict Formula measurement of Resting Energy Expenditure(REE).
OTHERCaloric Support (Group 2)
For group 2- dose of caloric support will be calculated by Indirect Calorimetric measurement of Resting Energy Expenditure(REE)
DIETARY_SUPPLEMENTProtein 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_SUPPLEMENTProtein 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_SUPPLEMENTprotein 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.
Sponsors
Beit Rivka Hospital
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of mechanical ventilation | At one, four and eight weeks | Length of mechanical ventilation in days/hours |
| 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 | — |
| Successful weaning from ventilation | At one, four and eight weeks | Spontaneous breathing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Infectious diseases incidence | At one, four and eight weeks | — |
Outcome results
None listed