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

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01142570
• Other study ID #: 5668
• Status: Active, not recruiting
• Phase: N/A
• First received: May 13, 2010
• Last updated: October 3, 2010
• Start date: September 2010
• Est. completion date: November 2012

Study information

• Verified date: January 2010
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

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).
• Caloric Support (Group 2)
For group 2- dose of caloric support will be calculated by Indirect Calorimetric measurement of Resting Energy Expenditure(REE)

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Beit Rivka Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful weaning from ventilation	Spontaneous breathing	At one, four and eight weeks	No
Primary	Length of hospital stay	Length of hospitalization, in days	At 8 weeks	No
Primary	Readmission to Intensive Care Unit		At four and eight weeks.	No
Primary	Readmission to Intensive Care Unit Mortality		At eight weeks	No
Primary	Length of mechanical ventilation	Length of mechanical ventilation in days/hours	At one, four and eight weeks	No
Secondary	Infectious diseases incidence		At one, four and eight weeks	No
Secondary	Development and progression of pressure ulcers		At one, four and eight weeks	No
Secondary	Checked daily insulin intake among different groups of patients	Glucose Control	After one, four and eight weeks	No