Critical IllnessPhase 4NCT00574431
ICU Nutrition Study Bern
A Phase 4 study testing Data Collection and Nutritional management protocol in people with Critical Illness and Starvation, run by Insel Gruppe AG, University Hospital Bern.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Starvation, Enteral Nutrition
- What is being tested?
- Data Collection and Nutritional management protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Mar 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- <18 years of age
- stay less than 72 hours on ICU
- die within 72h after admission
- patients admitted for palliative care
About this study
Official title: 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.
- Conditions
- Critical Illness, Starvation, Enteral Nutrition
- Being tested
- Data Collection, Nutritional management protocol
- Keywords
- Critical care, Intensive care unit, Early enteral nutrition, Nutritional management protocol
- Medical subject headings
- Critical Illness, Starvation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
Collection of patient data before implementation of a nutritional management protocol
Nutritional management protocolOther
Collection of patient data after implementation of a nutritional management protocol
| Study group | Role | What they receive |
|---|---|---|
| Observation | Other | Observation Receives: Other: Data Collection |
| Nutritional management protocol | Active comparator | Collection of patient data after implementation of a nutritional management protocol Receives: Other: Nutritional management protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy delivered (%of caloric target) before and after introducing the nutritional management protocol.
Measured: During ICU stay
Protein delivered (% of caloric target) before and after introducing the nutritional management protocol
Measured: During ICU stay
Start of enteral feeding after ICU admission
Measured: During ICU stay
Secondary outcomes (6)
ICU mortality
Measured: During ICU stay
Hospital mortality
Measured: During hospital stay
length of ICU stay
Measured: During ICU stay
length of hospital stay
Measured: During hospital stay
use of antibiotics (days)
Measured: During ICU stay
rate of accurately defined infections
Measured: During ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startFeb 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition
- Investigators
- Michele Leuenberger, MD, Principal investigator, University of BernStephan M Jakob, MD, PHD, Study director, University of BernZeno Stanga, MD, Principal investigator, University of BernMargaret Schafer, MD, Principal investigator, University of BernJukka Takala, MD, PHD, Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574431
- Sponsor's protocol ID
- ICU Nutr Bern
- Status last verified
- Mar 2011
- First submitted
- 14 Dec 2007
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Evidence-based Nutritional Management Protocol in Critically Ill Patients:Does Clinical Outcome Improve?
- ClinicalTrials.gov ID
- NCT00574431
- Acronym / sponsor ID
- ICU Nutr Bern
- Conditions
- Critical Illness, Starvation, Enteral Nutrition
- Keywords
- Critical care, Intensive care unit, Early enteral nutrition, Nutritional management protocol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Abbott Nutrition
- Study start
- Feb 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | Other | Other: Data CollectionObservation |
| Nutritional management protocol | Active comparator | Other: Nutritional management protocolCollection of patient data after implementation of a nutritional management protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- <18 years of age
- stay less than 72 hours on ICU
- die within 72h after admission
- patients admitted for palliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CollectionCollection of patient data before implementation of a nutritional management protocol | Other | Observation |
| Nutritional management protocolCollection of patient data after implementation of a nutritional management protocol | Other | Nutritional management protocol |
Primary outcome
Energy delivered (%of caloric target) before and after introducing the nutritional management protocol.
Time frame: During ICU stay
Protein delivered (% of caloric target) before and after introducing the nutritional management protocol
Time frame: During ICU stay
Start of enteral feeding after ICU admission
Time frame: During ICU stay
6 secondary outcomes
ICU mortality
Time frame: During ICU stay
Hospital mortality
Time frame: During hospital stay
length of ICU stay
Time frame: During ICU stay
length of hospital stay
Time frame: During hospital stay
use of antibiotics (days)
Time frame: During ICU stay
rate of accurately defined infections
Time frame: During ICU stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Leuenberger, MD principal investigator
University of Bern
Stephan M Jakob, MD, PHD study director
University of Bern
Zeno Stanga, MD principal investigator
University of Bern
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Data Collection and Nutritional management protocol in people with Critical Illness and Starvation, run by Insel Gruppe AG, University Hospital Bern.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy delivered (%of caloric target) before and after introducing the nutritional management protocol. (time frame: During ICU stay). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.