Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beit Rivka Hospital | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Outcome of treatment results will be performed after one ,four and eight weeks:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Patients will be receive caloric support as dictated by Hariss-Benedict Formula (Group 1) |
|
| Group 2 | Active Comparator | Patients will be receive caloric support as dictated by Indirect Calorimetry (Group 2) |
|
| Group 1A | Active Comparator | 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 | Active Comparator | 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 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caloric Support (Group 1) | Other | Four group 1-dose of caloric support will be calculated by Hariss-Benedict Formula measurement of Resting Energy Expenditure(REE). |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gregory Papirov, MD | Beit- Rivka Hospital, Petah-Tikva, Israel | Principal Investigator |
| Pierre Singer, MD, Professor | ICU, Rabin Medical Center,Petah- Tikva, Israel | Study Director |
| Ludmila Zaidenberg, MD | Beit Rivka hospital, Petah- Tikva, Israel | Study Director |
| Milana Grinev, RN,Study Coordinator | ICU, Rabin Medical Center,Petah- Tikva, Israel | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
|
| Caloric Support (Group 2) | Other | For group 2- dose of caloric support will be calculated by Indirect Calorimetric measurement of Resting Energy Expenditure(REE) |
|
| Protein dose of 1.1 to 1.5 grams per kilogram weight. | Dietary Supplement | 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. |
|
| Protein at 1.1 grams per kilogram weight. | Dietary Supplement | 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. |
|
| protein at a dose of 1.5 grams per kilogram weight. | Dietary Supplement | 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. |
|
Glucose Control |
| After one, four and eight weeks |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided