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CompletedNCT00574431Updated Jul 14, 2015

ICU Nutrition Study Bern

A Phase 4 interventional study of Data Collection and Nutritional management protocol in Critical Illness, Starvation and Enteral Nutrition, sponsored by Insel Gruppe AG, University Hospital Bern. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-14.

Sponsored by Insel Gruppe AG, University Hospital Bern · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Critical Illness
  • Starvation
  • Enteral Nutrition

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Keywords

  • Critical care
  • Intensive care unit
  • Early enteral nutrition
  • Nutritional management protocol
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 200 is above the median of 90 across 979 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Exclusion Criteria:

  • \<18 years of age
  • stay less than 72 hours on ICU
  • die within 72h after admission
  • patients admitted for palliative care
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Other
    Observation

    Observation

    Other: Data Collection

  • Active comparator
    Nutritional management protocol

    Collection of patient data after implementation of a nutritional management protocol

    Other: Nutritional management protocol

Interventions

  • OtherData Collection

    Collection of patient data before implementation of a nutritional management protocol

  • OtherNutritional management protocol

    Collection of patient data after implementation of a nutritional management protocol

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What researchers measure

Primary outcomes

  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 outcomes

  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

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00574431
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Abbott Nutrition
First posted
Dec 17, 2007
Start date
Feb 2008
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Jul 14, 2015

Study contacts

Michele Leuenberger, MD
principal investigator · University hospital of Bern
Stephan M Jakob, MD, PHD
study director · University hospital of Bern
Zeno Stanga, MD
principal investigator · University hospital of Bern
Margaret Schafer, MD
principal investigator · University hospital of Bern
Jukka Takala, MD, PHD
study chair · University hospital of Bern

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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