Overview

This trial is active, not recruiting.

Condition critically ill
Treatments caloric support (group 1), caloric support (group 2), protein dose of 1.1 to 1.5 grams per kilogram weight., protein at 1.1 grams per kilogram weight., protein at a dose of 1.5 grams per kilogram weight.
Sponsor Rabin Medical Center
Collaborator Beit Rivka Hospital
Start date September 2010
End date September 2012
Trial size 60 participants
Trial identifier NCT01142570, 5668

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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).
(Active Comparator)
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)
(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.
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)
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.
(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 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.

Primary Outcomes

Measure
Successful weaning from ventilation
time frame: At one, four and eight weeks
Length of hospital stay
time frame: At 8 weeks
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

Secondary Outcomes

Measure
Infectious diseases incidence
time frame: At one, four and eight weeks
Development and progression of pressure ulcers
time frame: At one, four and eight weeks
Checked daily insulin intake among different groups of patients
time frame: After one, four and eight weeks

Eligibility Criteria

Male or female participants from 65 years up to 90 years old.

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

Additional Information

Official title Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients
Principal investigator Gregory Papirov, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by Rabin Medical Center.