ICU Nutrition Study Bern

Critical Illness Clinical Trial

Official title:

Implementation of an Evidence-based Nutritional Management Protocol in Critically Ill Patients:Does Clinical Outcome Improve?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574431
• Other study ID #: ICU Nutr Bern
• Status: Completed
• Phase: Phase 4
• First received: December 14, 2007
• Last updated: July 13, 2015
• Start date: February 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2011
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Exclusion Criteria:

• <18 years of age

• stay less than 72 hours on ICU

• die within 72h after admission

• patients admitted for palliative care

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Enteral Nutrition
• Starvation

Intervention

Other:
• Data Collection
Collection of patient data before implementation of a nutritional management protocol
• Nutritional management protocol
Collection of patient data after implementation of a nutritional management protocol

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Abbott Nutrition

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy delivered (%of caloric target) before and after introducing the nutritional management protocol.		During ICU stay	No
Primary	Protein delivered (% of caloric target) before and after introducing the nutritional management protocol		During ICU stay	No
Primary	Start of enteral feeding after ICU admission		During ICU stay	No
Secondary	ICU mortality		During ICU stay	No
Secondary	Hospital mortality		During hospital stay	No
Secondary	length of ICU stay		During ICU stay	No
Secondary	length of hospital stay		During hospital stay	No
Secondary	use of antibiotics (days)		During ICU stay	No
Secondary	rate of accurately defined infections		During ICU stay	No