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ICU Nutrition Study Bern

This study has been completed.
Sponsor:
Collaborator:
Abbott Nutrition
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00574431
First received: December 14, 2007
Last updated: March 10, 2011
Last verified: March 2011
History of Changes

December 14, 2007
March 10, 2011
February 2008
March 2009   (final data collection date for primary outcome measure)
  • Energy delivered (%of caloric target) before and after introducing the nutritional management protocol. [ Time Frame: During ICU stay ] [ Designated as safety issue: No ]
  • Protein delivered (% of caloric target) before and after introducing the nutritional management protocol [ Time Frame: During ICU stay ] [ Designated as safety issue: No ]
  • Start of enteral feeding after ICU admission [ Time Frame: During ICU stay ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00574431 on ClinicalTrials.gov Archive Site
  • ICU mortality [ Time Frame: During ICU stay ] [ Designated as safety issue: No ]
  • Hospital mortality [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
  • length of ICU stay [ Time Frame: During ICU stay ] [ Designated as safety issue: No ]
  • length of hospital stay [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
  • use of antibiotics (days) [ Time Frame: During ICU stay ] [ Designated as safety issue: No ]
  • rate of accurately defined infections [ Time Frame: During ICU stay ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
ICU Nutrition Study Bern
Implementation of an Evidence-based Nutritional Management Protocol in Critically Ill Patients:Does Clinical Outcome Improve?

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Critical Illness
  • Starvation
  • Enteral Nutrition
  • Other: Data Collection
    Collection of patient data before implementation of a nutritional management protocol
  • Other: Nutritional management protocol
    Collection of patient data after implementation of a nutritional management protocol
  • No Intervention: I
    Observation
    Intervention: Other: Data Collection
  • Active Comparator: II
    Collection of patient data after implementation of a nutritional management protocol
    Intervention: Other: Nutritional management protocol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
March 2009
March 2009   (final data collection date for primary outcome measure)

Exclusion Criteria:

  • <18 years of age
  • stay less than 72 hours on ICU
  • die within 72h after admission
  • patients admitted for palliative care
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00574431
ICU Nutr Bern
No
Bern University Hospital, Department of Intensive Care Medicine, Bern University Hospital, and University of Bern, Switzerland
University Hospital Inselspital, Berne
Abbott Nutrition
Principal Investigator: Michele Leuenberger, MD University Hospital of Bern
Study Director: Stephan M Jakob, MD, PHD University Hospital of Bern
Principal Investigator: Zeno Stanga, MD University Hospital of Bern
Principal Investigator: Margaret Schafer, MD University Hospital of Bern
Study Chair: Jukka Takala, MD, PHD University Hospital of Bern
University Hospital Inselspital, Berne
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP