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

NCT01142570 | Unknown DMC

• 1 other identifier: 5668
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critically Ill

Keywords

Mechanical Ventilation

Outcome Measures

Primary Outcomes (5)

• Successful weaning from ventilation

  Spontaneous breathing

  At one, four and eight weeks

• Length of hospital stay

  Length of hospitalization, in days

  At 8 weeks

• Readmission to Intensive Care Unit

  At four and eight weeks.

• Readmission to Intensive Care Unit Mortality

  At eight weeks

• Length of mechanical ventilation

  Length of mechanical ventilation in days/hours

  At one, four and eight weeks

Secondary Outcomes (3)

• Infectious diseases incidence

  At one, four and eight weeks

• Development and progression of pressure ulcers

  At one, four and eight weeks

• Checked daily insulin intake among different groups of patients

  After one, four and eight weeks

Study Arms (5)

Group 1

ACTIVE COMPARATOR

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

Other: Caloric Support (Group 1)

Group 2

ACTIVE COMPARATOR

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

Other: Caloric Support (Group 2)

Group 1A

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.

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

Group 2A

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.

Dietary Supplement: Protein at 1.1 grams per kilogram weight.

Group 3A

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.

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

Interventions

Caloric Support (Group 1) OTHER

Four group 1-dose of caloric support will be calculated by Hariss-Benedict Formula measurement of Resting Energy Expenditure(REE).

Group 1

Caloric Support (Group 2) OTHER

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

Group 2

Protein dose of 1.1 to 1.5 grams per kilogram weight. DIETARY_SUPPLEMENT

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.

Group 1A

Protein at 1.1 grams per kilogram weight. DIETARY_SUPPLEMENT

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.

Group 2A

protein at a dose of 1.5 grams per kilogram weight. DIETARY_SUPPLEMENT

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.

Group 3A

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Chronically Mechanical Ventilated Patients (more than 21 days of Mechanical Ventilation) by tracheostomy,
• Between ages 65-90

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead
• Beit Rivka Hospital: collaborator

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory Papirov, MD

  Beit- Rivka Hospital, Petah-Tikva, Israel

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: June 11, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 5, 2010

Record last verified: 2010-01