Clinical trial NCT01142570: Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients
Official title: Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critically Ill
Keywords: Mechanical Ventilation
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Beit Rivka Hospital
First posted: 2010-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Successful weaning from ventilation
timeFrame: At one, four and eight weeks
measure: Length of hospital stay
timeFrame: At 8 weeks
measure: Readmission to Intensive Care Unit
timeFrame: At four and eight weeks.
measure: Readmission to Intensive Care Unit Mortality
timeFrame: At eight weeks
measure: Length of mechanical ventilation
timeFrame: At one, four and eight weeks
Secondary outcomes:
measure: Infectious diseases incidence
timeFrame: At one, four and eight weeks
measure: Development and progression of pressure ulcers
timeFrame: At one, four and eight weeks
measure: Checked daily insulin intake among different groups of patients
timeFrame: After one, four and eight weeks
Other outcomes:
Locations:
Study officials:
affiliation: Beit- Rivka Hospital, Petah-Tikva, Israel
name: Gregory Papirov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ICU, Rabin Medical Center,Petah- Tikva, Israel
name: Pierre Singer, MD, Professor
role: STUDY_DIRECTOR
affiliation: Beit Rivka hospital, Petah- Tikva, Israel
name: Ludmila Zaidenberg, MD
role: STUDY_DIRECTOR
affiliation: ICU, Rabin Medical Center,Petah- Tikva, Israel
name: Milana Grinev, RN,Study Coordinator
role: STUDY_DIRECTOR
References: