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

Primary Purpose

Critically Ill

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Caloric Support (Group 1)
Caloric Support (Group 2)
Protein dose of 1.1 to 1.5 grams per kilogram weight.
Protein at 1.1 grams per kilogram weight.
protein at a dose of 1.5 grams per kilogram weight.
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill focused on measuring Mechanical Ventilation

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Group 1A

    Group 2A

    Group 3A

    Arm Description

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

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

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Successful weaning from ventilation
    Spontaneous breathing
    Length of hospital stay
    Length of hospitalization, in days
    Readmission to Intensive Care Unit
    Readmission to Intensive Care Unit Mortality
    Length of mechanical ventilation
    Length of mechanical ventilation in days/hours

    Secondary Outcome Measures

    Infectious diseases incidence
    Development and progression of pressure ulcers
    Checked daily insulin intake among different groups of patients
    Glucose Control

    Full Information

    First Posted
    May 13, 2010
    Last Updated
    October 3, 2010
    Sponsor
    Rabin Medical Center
    Collaborators
    Beit Rivka Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01142570
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2010 (undefined)
    Primary Completion Date
    September 2012 (Anticipated)
    Study Completion Date
    November 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Rabin Medical Center
    Collaborators
    Beit Rivka Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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. 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. 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. 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: Length of hospitalization Weaning from Mechanical Ventilation Development and progression of pressure ulcers Infectious diseases incidence Amount of insulin needed for glucose control Length of mechanical ventilation Readmission to Intensive Care Unit Mortality rate

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critically Ill
    Keywords
    Mechanical Ventilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    Patients will be receive caloric support as dictated by Hariss-Benedict Formula (Group 1)
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    Patients will be receive caloric support as dictated by Indirect Calorimetry (Group 2)
    Arm Title
    Group 1A
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Group 2A
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Group 3A
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Caloric Support (Group 1)
    Intervention Description
    Four group 1-dose of caloric support will be calculated by Hariss-Benedict Formula measurement of Resting Energy Expenditure(REE).
    Intervention Type
    Other
    Intervention Name(s)
    Caloric Support (Group 2)
    Intervention Description
    For group 2- dose of caloric support will be calculated by Indirect Calorimetric measurement of Resting Energy Expenditure(REE)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Protein dose of 1.1 to 1.5 grams per kilogram weight.
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Protein at 1.1 grams per kilogram weight.
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    protein at a dose of 1.5 grams per kilogram weight.
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Successful weaning from ventilation
    Description
    Spontaneous breathing
    Time Frame
    At one, four and eight weeks
    Title
    Length of hospital stay
    Description
    Length of hospitalization, in days
    Time Frame
    At 8 weeks
    Title
    Readmission to Intensive Care Unit
    Time Frame
    At four and eight weeks.
    Title
    Readmission to Intensive Care Unit Mortality
    Time Frame
    At eight weeks
    Title
    Length of mechanical ventilation
    Description
    Length of mechanical ventilation in days/hours
    Time Frame
    At one, four and eight weeks
    Secondary Outcome Measure Information:
    Title
    Infectious diseases incidence
    Time Frame
    At one, four and eight weeks
    Title
    Development and progression of pressure ulcers
    Time Frame
    At one, four and eight weeks
    Title
    Checked daily insulin intake among different groups of patients
    Description
    Glucose Control
    Time Frame
    After one, four and eight weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gregory Papirov, MD
    Organizational Affiliation
    Beit- Rivka Hospital, Petah-Tikva, Israel
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Pierre Singer, MD, Professor
    Organizational Affiliation
    ICU, Rabin Medical Center,Petah- Tikva, Israel
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ludmila Zaidenberg, MD
    Organizational Affiliation
    Beit Rivka hospital, Petah- Tikva, Israel
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Milana Grinev, RN,Study Coordinator
    Organizational Affiliation
    ICU, Rabin Medical Center,Petah- Tikva, Israel
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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