ICU Nutrition Study Bern - Full Text View

Sponsors and Collaborators:	University Hospital Inselspital, Berne Abbott Nutrition
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00574431

Purpose

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.

Condition	Intervention	Phase
Critical Illness Starvation Enteral Nutrition	Other: Data Collection Other: Nutritional management protocol	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Implementation of an Evidence-Based Nutritional Management Protocol in Critically Ill Patients:Does Clinical Outcome Improve?

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
I: No Intervention Observation	Other: Data Collection Collection of patient data before implementation of a nutritional management protocol
II: Active Comparator Collection of patient data after implementation of a nutritional management protocol	Other: Nutritional management protocol Collection of patient data after implementation of a nutritional management protocol

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574431

Contacts

Contact: Stephan Jakob, MD, PHD	+41 31 632 11 78	stephan.jakob@insel.ch
Contact: Zeno Stanga, MD	+41 31 632 42 46	zeno.stanga@insel.ch

Locations

Switzerland, BE
University Hospital	Recruiting
Bern, BE, Switzerland, 3010
Principal Investigator: Stephan M Jakob, MD
Sub-Investigator: Margaret Schafer, MD

Sponsors and Collaborators

University Hospital Inselspital, Berne

Abbott Nutrition

Investigators

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

More Information

Responsible Party:	Department of Intensive Care Medicine, Bern University Hospital, and University of Bern, Switzerland ( Bern University Hospital )
Study ID Numbers:	ICU Nutr Bern
Study First Received:	December 14, 2007
Last Updated:	February 7, 2008
ClinicalTrials.gov Identifier:	NCT00574431
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:

Critical care
Intensive care unit
Early enteral nutrition
Nutritional management protocol

Study placed in the following topic categories:

Starvation
Malnutrition
Critical Illness
Nutrition Disorders

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009