Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients
NCT ID: NCT01142570
Last Updated: 2010-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2010-09-30
2012-11-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1
Patients will be receive caloric support as dictated by Hariss-Benedict Formula (Group 1)
Caloric Support (Group 1)
Four group 1-dose of caloric support will be calculated by Hariss-Benedict Formula measurement of Resting Energy Expenditure(REE).
Group 2
Patients will be receive caloric support as dictated by Indirect Calorimetry (Group 2)
Caloric Support (Group 2)
For group 2- dose of caloric support will be calculated by Indirect Calorimetric measurement of Resting Energy Expenditure(REE)
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.
Protein 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.
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.
Protein 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.
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.
protein 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.
Interventions
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Caloric Support (Group 1)
Four group 1-dose of caloric support will be calculated by Hariss-Benedict Formula measurement of Resting Energy Expenditure(REE).
Caloric Support (Group 2)
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Between ages 65-90
Exclusion Criteria
* PH level less than 7.3 due to metabolic causes.
* A patient with blood albumin level less than 2.2 g / dl
65 Years
90 Years
ALL
No
Sponsors
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Beit Rivka Hospital
UNKNOWN
Rabin Medical Center
OTHER
Responsible Party
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Beit Rivka Hospital , Geriatric medical center, Petah Tikva, Clalit Health Services
Principal Investigators
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Gregory Papirov, MD
Role: PRINCIPAL_INVESTIGATOR
Beit- Rivka Hospital, Petah-Tikva, Israel
Pierre Singer, MD, Professor
Role: STUDY_DIRECTOR
ICU, Rabin Medical Center,Petah- Tikva, Israel
Ludmila Zaidenberg, MD
Role: STUDY_DIRECTOR
Beit Rivka hospital, Petah- Tikva, Israel
Milana Grinev, RN,Study Coordinator
Role: STUDY_DIRECTOR
ICU, Rabin Medical Center,Petah- Tikva, Israel
Other Identifiers
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5668
Identifier Type: -
Identifier Source: org_study_id