Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients
Study Overview
Status
Conditions
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.
- 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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Group 1
Patients will be receive caloric support as dictated by Hariss-Benedict Formula (Group 1)
|
Four group 1-dose of caloric support will be calculated by Hariss-Benedict Formula measurement of Resting Energy Expenditure(REE).
|
|
ACTIVE_COMPARATOR: Group 2
Patients will be receive caloric support as dictated by Indirect Calorimetry (Group 2)
|
For group 2- dose of caloric support will be calculated by Indirect Calorimetric measurement of Resting Energy Expenditure(REE)
|
|
ACTIVE_COMPARATOR: 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. |
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.
|
|
ACTIVE_COMPARATOR: 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. |
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.
|
|
ACTIVE_COMPARATOR: 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Successful weaning from ventilation
Time Frame: At one, four and eight weeks
|
Spontaneous breathing
|
At one, four and eight weeks
|
|
Length of hospital stay
Time Frame: At 8 weeks
|
Length of hospitalization, in days
|
At 8 weeks
|
|
Readmission to Intensive Care Unit
Time Frame: At four and eight weeks.
|
At four and eight weeks.
|
|
|
Readmission to Intensive Care Unit Mortality
Time Frame: At eight weeks
|
At eight weeks
|
|
|
Length of mechanical ventilation
Time Frame: At one, four and eight weeks
|
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
Time Frame: At one, four and eight weeks
|
At one, four and eight weeks
|
|
|
Development and progression of pressure ulcers
Time Frame: At one, four and eight weeks
|
At one, four and eight weeks
|
|
|
Checked daily insulin intake among different groups of patients
Time Frame: After one, four and eight weeks
|
Glucose Control
|
After one, four and eight weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gregory Papirov, MD, Beit- Rivka Hospital, Petah-Tikva, Israel
- Study Director: 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 record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5668
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