Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Rabin Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Beit Rivka Hospital
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01142570
First received: May 13, 2010
Last updated: October 3, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Critically Ill
Other: Caloric Support (Group 1)
Other: Caloric Support (Group 2)
Dietary Supplement: Protein dose of 1.1 to 1.5 grams per kilogram weight.
Dietary Supplement: Protein at 1.1 grams per kilogram weight.
Dietary Supplement: protein at a dose of 1.5 grams per kilogram weight.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Successful weaning from ventilation [ Time Frame: At one, four and eight weeks ] [ Designated as safety issue: No ]
    Spontaneous breathing

  • Length of hospital stay [ Time Frame: At 8 weeks ] [ Designated as safety issue: No ]
    Length of hospitalization, in days

  • Readmission to Intensive Care Unit [ Time Frame: At four and eight weeks. ] [ Designated as safety issue: No ]
  • Readmission to Intensive Care Unit Mortality [ Time Frame: At eight weeks ] [ Designated as safety issue: No ]
  • Length of mechanical ventilation [ Time Frame: At one, four and eight weeks ] [ Designated as safety issue: No ]
    Length of mechanical ventilation in days/hours


Secondary Outcome Measures:
  • Infectious diseases incidence [ Time Frame: At one, four and eight weeks ] [ Designated as safety issue: No ]
  • Development and progression of pressure ulcers [ Time Frame: At one, four and eight weeks ] [ Designated as safety issue: No ]
  • Checked daily insulin intake among different groups of patients [ Time Frame: After one, four and eight weeks ] [ Designated as safety issue: No ]
    Glucose Control


Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Patients will be receive caloric support as dictated by Hariss-Benedict Formula (Group 1)
Other: 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: Group 2
Patients will be receive caloric support as dictated by Indirect Calorimetry (Group 2)
Other: 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: 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.

Dietary Supplement: 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.

Dietary Supplement: 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.

Dietary Supplement: 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.

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
  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142570

Sponsors and Collaborators
Rabin Medical Center
Beit Rivka Hospital
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
  More Information

No publications provided

Responsible Party: Dr. Papirov Gregory, Beit Rivka Hospital , Geriatric medical center, Petah Tikva, Clalit Health Services
ClinicalTrials.gov Identifier: NCT01142570     History of Changes
Other Study ID Numbers: 5668
Study First Received: May 13, 2010
Last Updated: October 3, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Mechanical Ventilation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014