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ICU Nutrition Study Bern

Primary Purpose

Critical Illness, Starvation, Enteral Nutrition

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Data Collection
Nutritional management protocol
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Critical care, Intensive care unit, Early enteral nutrition, Nutritional management protocol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Exclusion Criteria:

  • <18 years of age
  • stay less than 72 hours on ICU
  • die within 72h after admission
  • patients admitted for palliative care

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    Observation

    Nutritional management protocol

    Arm Description

    Observation

    Collection of patient data after implementation of a nutritional management protocol

    Outcomes

    Primary Outcome Measures

    Energy delivered (%of caloric target) before and after introducing the nutritional management protocol.
    Protein delivered (% of caloric target) before and after introducing the nutritional management protocol
    Start of enteral feeding after ICU admission

    Secondary Outcome Measures

    ICU mortality
    Hospital mortality
    length of ICU stay
    length of hospital stay
    use of antibiotics (days)
    rate of accurately defined infections

    Full Information

    First Posted
    December 14, 2007
    Last Updated
    July 13, 2015
    Sponsor
    Insel Gruppe AG, University Hospital Bern
    Collaborators
    Abbott Nutrition
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00574431
    Brief Title
    ICU Nutrition Study Bern
    Official Title
    Implementation of an Evidence-based Nutritional Management Protocol in Critically Ill Patients:Does Clinical Outcome Improve?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2008 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Insel Gruppe AG, University Hospital Bern
    Collaborators
    Abbott Nutrition

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Nutritional treatment has become an essential component of the management of critically ill, due to better knowledge about positive impact of nutritional support. Malnutrition among ICU patients is associated with increased morbidity, mortality, length of stay (LOS) and therefore higher costs.Several studies however suggest, that early implementation of nutritional support is associated with improved clinical outcome, shorter LOS, and decreased infection rates. One of the objectives of this study is to determine if an nutrition protocol can improve the delivery of enteral tube feeding in the ICU.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical Illness, Starvation, Enteral Nutrition
    Keywords
    Critical care, Intensive care unit, Early enteral nutrition, Nutritional management protocol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Observation
    Arm Type
    Other
    Arm Description
    Observation
    Arm Title
    Nutritional management protocol
    Arm Type
    Active Comparator
    Arm Description
    Collection of patient data after implementation of a nutritional management protocol
    Intervention Type
    Other
    Intervention Name(s)
    Data Collection
    Intervention Description
    Collection of patient data before implementation of a nutritional management protocol
    Intervention Type
    Other
    Intervention Name(s)
    Nutritional management protocol
    Intervention Description
    Collection of patient data after implementation of a nutritional management protocol
    Primary Outcome Measure Information:
    Title
    Energy delivered (%of caloric target) before and after introducing the nutritional management protocol.
    Time Frame
    During ICU stay
    Title
    Protein delivered (% of caloric target) before and after introducing the nutritional management protocol
    Time Frame
    During ICU stay
    Title
    Start of enteral feeding after ICU admission
    Time Frame
    During ICU stay
    Secondary Outcome Measure Information:
    Title
    ICU mortality
    Time Frame
    During ICU stay
    Title
    Hospital mortality
    Time Frame
    During hospital stay
    Title
    length of ICU stay
    Time Frame
    During ICU stay
    Title
    length of hospital stay
    Time Frame
    During hospital stay
    Title
    use of antibiotics (days)
    Time Frame
    During ICU stay
    Title
    rate of accurately defined infections
    Time Frame
    During ICU stay

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Exclusion Criteria: <18 years of age stay less than 72 hours on ICU die within 72h after admission patients admitted for palliative care
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michele Leuenberger, MD
    Organizational Affiliation
    University hospital of Bern
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Stephan M Jakob, MD, PHD
    Organizational Affiliation
    University hospital of Bern
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Zeno Stanga, MD
    Organizational Affiliation
    University hospital of Bern
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Margaret Schafer, MD
    Organizational Affiliation
    University hospital of Bern
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jukka Takala, MD, PHD
    Organizational Affiliation
    University hospital of Bern
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    ICU Nutrition Study Bern

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