Critical IllnessNCT01357200
Feeding Trial in the Obese Critical Care Population
An observational study of Critical Illness and Obesity, run by Société des Produits Nestlé (SPN) at 2 sites in United States.
Trial summary
This study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Obesity
- What is being tested?
- enteral formula
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to Dec 2013
- Phase
- Observational
- 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
Study population: critically ill obese adults
Who may be able to join
- Age ≥ 18 years
- Surgical or Medical intensive care unit (ICU) patient
- Body mass index (BMI) ≥ 30
Who cannot join
- pregnant or lactating
- unable to access gastrointestinal (GI) tract for feeding via tube
- other contraindication to tube feeding
- admitted with burns
- severe head trauma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky
Lexington, Kentucky, 40536
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Enteral Formula Tolerance in the Obese Critical Care Population
This study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula.
Read the detailed description
Assess enteral feeding goal with a higher protein whey based peptide formula in an obese critically ill population.
- Conditions
- Critical Illness, Obesity
- Being tested
- enteral formula
- Medical subject headings
- Critical Illness, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral formulaOther
Complete feeding of study enteral formula, route and regime prescribed by the physician.
| Study group | Role | What they receive |
|---|---|---|
| critically ill obese adults | Age ≥ 18 years, body mass index (BMI) ≥ 30, in intensive care unit (ICU) requiring tube feeding ≥ 3 days Receives: Other: enteral formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to feeding goal achievement
on all participants
Measured: up to 5 days
Secondary outcomes (4)
gastrointestinal measures assessment
on all participants
Measured: daily for up to 11 days
percent of nutrition goal met
on all participants
Measured: up to 5 days
serum biochemical markers assessment
on all participants
Measured: daily for up to 11 days
assessment of frequency and nature of adverse events
on all participants
Measured: daily for up to 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2013
- Study completionDec 2013
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 Société des Produits Nestlé (SPN)The 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357200
- Sponsor's protocol ID
- 10.02.US.CLI
- Status last verified
- Jan 2014
- First submitted
- 15 May 2011
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Formula Tolerance in the Obese Critical Care Population
- ClinicalTrials.gov ID
- NCT01357200
- Acronym / sponsor ID
- 10.02.US.CLI
- Conditions
- Critical Illness, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 May 2011 (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.
This study will assess enteral feeding in an obese critically ill population with a higher protein whey based peptide formula.
Detailed description
Assess enteral feeding goal with a higher protein whey based peptide formula in an obese critically ill population.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critically ill obese adults | – | Other: enteral formulaAge ≥ 18 years, body mass index (BMI) ≥ 30, in intensive care unit (ICU) requiring tube feeding ≥ 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill obese adults
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Surgical or Medical intensive care unit (ICU) patient
- Body mass index (BMI) ≥ 30
Key exclusion criteria (5 listed)
- pregnant or lactating
- unable to access gastrointestinal (GI) tract for feeding via tube
- other contraindication to tube feeding
- admitted with burns
- severe head trauma
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 |
|---|---|---|
| enteral formulaComplete feeding of study enteral formula, route and regime prescribed by the physician. | Other | critically ill obese adults |
Primary outcome
time to feeding goal achievement
Time frame: up to 5 days
on all participants
4 secondary outcomes
gastrointestinal measures assessment
Time frame: daily for up to 11 days
percent of nutrition goal met
Time frame: up to 5 days
serum biochemical markers assessment
Time frame: daily for up to 11 days
assessment of frequency and nature of adverse events
Time frame: daily for up to 11 days
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 30 Jan 2014.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Obesity, run by Société des Produits Nestlé (SPN) at 2 sites in United States.
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 3 inclusion and 5 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 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
time to feeding goal achievement (time frame: up to 5 days). 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 30 Jan 2014.