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

Clalit Health Services

Status: Unknown

Conditions: Critically Ill

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01142570

5668

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 5 patient groups

Group 1

Active Comparator group

Description:

Patients will be receive caloric support as dictated by Hariss-Benedict Formula (Group 1)

Treatment:

Other: Caloric Support (Group 1)

Group 2

Active Comparator group

Description:

Patients will be receive caloric support as dictated by Indirect Calorimetry (Group 2)

Treatment:

Other: Caloric Support (Group 2)

Group 1A

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Protein dose of 1.1 to 1.5 grams per kilogram weight.

Group 2A

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Protein at 1.1 grams per kilogram weight.

Group 3A

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: protein at a dose of 1.5 grams per kilogram weight.