ClinicalTrials.gov
ClinicalTrials.gov Menu

ICU Nutrition Study Bern

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00574431
Recruitment Status : Completed
First Posted : December 17, 2007
Last Update Posted : July 14, 2015
Sponsor:
Collaborator:
Abbott Nutrition
Information provided by:
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Critical Illness Starvation Enteral Nutrition Other: Data Collection Other: Nutritional management protocol Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation of an Evidence-based Nutritional Management Protocol in Critically Ill Patients:Does Clinical Outcome Improve?
Study Start Date : February 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Observation
Observation
Other: Data Collection
Collection of patient data before implementation of a nutritional management protocol

Active Comparator: Nutritional management protocol
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




Primary Outcome Measures :
  1. Energy delivered (%of caloric target) before and after introducing the nutritional management protocol. [ Time Frame: During ICU stay ]
  2. Protein delivered (% of caloric target) before and after introducing the nutritional management protocol [ Time Frame: During ICU stay ]
  3. Start of enteral feeding after ICU admission [ Time Frame: During ICU stay ]

Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: During ICU stay ]
  2. Hospital mortality [ Time Frame: During hospital stay ]
  3. length of ICU stay [ Time Frame: During ICU stay ]
  4. length of hospital stay [ Time Frame: During hospital stay ]
  5. use of antibiotics (days) [ Time Frame: During ICU stay ]
  6. rate of accurately defined infections [ Time Frame: During ICU stay ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574431


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

Responsible Party: Bern University Hospital, Department of Intensive Care Medicine, Bern University Hospital, and University of Bern, Switzerland
ClinicalTrials.gov Identifier: NCT00574431     History of Changes
Other Study ID Numbers: ICU Nutr Bern
First Posted: December 17, 2007    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: March 2011

Keywords provided by University Hospital Inselspital, Berne:
Critical care
Intensive care unit
Early enteral nutrition
Nutritional management protocol

Additional relevant MeSH terms:
Critical Illness
Starvation
Disease Attributes
Pathologic Processes
Malnutrition
Nutrition Disorders