NCT00574431

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 14, 2015

Status Verified

March 1, 2011

Enrollment Period

1.1 years

First QC Date

December 14, 2007

Last Update Submit

July 13, 2015

Conditions

Critical IllnessStarvationEnteral Nutrition

Keywords

Critical careIntensive care unitEarly enteral nutritionNutritional management protocol

Outcome Measures

Primary Outcomes (3)

  • Energy delivered (%of caloric target) before and after introducing the nutritional management protocol.

    During ICU stay

  • Protein delivered (% of caloric target) before and after introducing the nutritional management protocol

    During ICU stay

  • Start of enteral feeding after ICU admission

    During ICU stay

Secondary Outcomes (6)

  • ICU mortality

    During ICU stay

  • Hospital mortality

    During hospital stay

  • length of ICU stay

    During ICU stay

  • length of hospital stay

    During hospital stay

  • use of antibiotics (days)

    During ICU stay

  • +1 more secondary outcomes

Study Arms (2)

Observation

OTHER

Observation

Other: Data Collection

Nutritional management protocol

ACTIVE COMPARATOR

Collection of patient data after implementation of a nutritional management protocol

Other: Nutritional management protocol

Interventions

Data CollectionOTHER

Collection of patient data before implementation of a nutritional management protocol

Observation
Nutritional management protocolOTHER

Collection of patient data after implementation of a nutritional management protocol

Nutritional management protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Critical IllnessStarvation

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Michele Leuenberger, MD

    University hospital of Bern

    PRINCIPAL INVESTIGATOR

  • Stephan M Jakob, MD, PHD

    University hospital of Bern

    STUDY DIRECTOR

  • Zeno Stanga, MD

    University hospital of Bern

    PRINCIPAL INVESTIGATOR

  • Margaret Schafer, MD

    University hospital of Bern

    PRINCIPAL INVESTIGATOR

  • Jukka Takala, MD, PHD

    University hospital of Bern

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2007

First Posted

December 17, 2007

Study Start

February 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 14, 2015

Record last verified: 2011-03