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
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

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.

Sponsor

University Hospital Inselspital, Berne

Collaborators

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

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

Keywords

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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