- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00574431
ICU Nutrition Study Bern
July 13, 2015 updated by: University Hospital Inselspital, Berne
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Exclusion Criteria:
- <18 years of age
- stay less than 72 hours on ICU
- die within 72h after admission
- patients admitted for palliative care
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Observation
|
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
|
Collection of patient data after implementation of a nutritional management protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Energy delivered (%of caloric target) before and after introducing the nutritional management protocol.
Time Frame: During ICU stay
|
During ICU stay
|
Protein delivered (% of caloric target) before and after introducing the nutritional management protocol
Time Frame: During ICU stay
|
During ICU stay
|
Start of enteral feeding after ICU admission
Time Frame: During ICU stay
|
During ICU stay
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ICU mortality
Time Frame: During ICU stay
|
During ICU stay
|
Hospital mortality
Time Frame: During hospital stay
|
During hospital stay
|
length of ICU stay
Time Frame: During ICU stay
|
During ICU stay
|
length of hospital stay
Time Frame: During hospital stay
|
During hospital stay
|
use of antibiotics (days)
Time Frame: During ICU stay
|
During ICU stay
|
rate of accurately defined infections
Time Frame: During ICU stay
|
During ICU stay
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
December 14, 2007
First Submitted That Met QC Criteria
December 14, 2007
First Posted (Estimate)
December 17, 2007
Study Record Updates
Last Update Posted (Estimate)
July 14, 2015
Last Update Submitted That Met QC Criteria
July 13, 2015
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICU Nutr Bern
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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