Enteral FeedingNCT00480259
Hyperproteic Nutrition:Correlation of BUN to Nitrogen Balance
A study testing hyperproteic nutrition in people with Enteral Feeding, run by Milton S. Hershey Medical Center.
Trial summary
This study is designed to determine if the following are true. When protein requirements exceed metabolic requirements, blood urea nitrogen(BUN) levels will rise. Elevated BUN levels in the absence of renal failure, hepatic failure, or GI bleeding, will be correlated with improved nitrogen balance and inversely… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Feeding
- What is being tested?
- hyperproteic nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2007to 21 Apr 2009
- Phase
- Interventional
- 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
- Greater then or equal to 18 years of age and patient in Intensive Care Unit
- Receiving enteral nutrition, with expected duration of at least 5 days
- Blood urea nitrogen and creatinine clearance are part of routine blood work
- Indwelling urinary catheter in place
Who cannot join
- Renal or hepatic failure
- Current or history(past 6 mos) of GI bleeding
- Serum creatinine on day of screening of equal to or greater then 1.5 mg/dl
- Creatinine Clearance on day of screening of equal to or less then 30ml/min
- Hypovolemia resulting in increased BUN
- Septic shock
- Blood urea nitrogen on day of screening equal to or greater then 30mg/dl
About this study
Official title: Hyperproteic Nutrition; Correlation of BUN to Nitrogen Balance and Associated Infection Rates With Bimodal Protein Administration
This study is designed to determine if the following are true. When protein requirements exceed metabolic requirements, blood urea nitrogen(BUN) levels will rise. Elevated BUN levels in the absence of renal failure, hepatic failure, or GI bleeding, will be correlated with improved nitrogen balance and inversely correlated with infection rates, days of mechanical ventilation, ICU days, and total hospital days.
Read the detailed description
The purpose of this study is threefold. First, to determine if a correlation exists between BUN and nitrogen balance in the context of hyperproteic nutrition administration. Creatinine clearance will also be followed to determine if there is any harmful effect to the kidney secondary to an elevated BUN. Secondly, to determine if there is a difference in hospital acquired infection rate, ventilator days, ICU days, and hospital stay between the current nutrition standard at Penn State Hershey Medical Center and a hyperproteic nutrition protocol. Thirdly, to determine the accuracy of at least three calculated creatinine clearance formulae when compared to a measured creatinine clearance.
- Conditions
- Enteral Feeding
- Being tested
- hyperproteic nutrition
- Keywords
- blood urea nitrogen, nitrogen balance, nutrition, intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperproteic nutritionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Standard Nutrition | Active comparator | Not described Receives: Behavioral: hyperproteic nutrition |
| Hyperprotein Nutrition | Experimental | Not described Receives: Behavioral: hyperproteic nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in BUN
Measured: Unable to document -incomplete information and investigator no longer at institution; no records available
Secondary outcomes (1)
Decrease in infection rate, ventilator days, ICU stay and hospital dys
Measured: Unable to document -incomplete information and investigator no longer at institution; no records available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
- Study start1 Jun 2007
- Primary completion21 Apr 2009
- Study completion21 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral FeedingStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John K Stene, MD, Principal investigator, Penn State University, College of Medicine, Dept of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480259
- Sponsor's protocol ID
- 25351
- Status last verified
- May 2018
- First submitted
- 29 May 2007
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperproteic Nutrition; Correlation of BUN to Nitrogen Balance and Associated Infection Rates With Bimodal Protein Administration
- ClinicalTrials.gov ID
- NCT00480259
- Acronym / sponsor ID
- 25351
- Conditions
- Enteral Feeding
- Keywords
- blood urea nitrogen, nitrogen balance, nutrition, intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2007 (actual)
- Primary completion
- 21 Apr 2009 (actual)
- Study completion
- 21 Apr 2009 (actual)
- First posted
- 30 May 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.
This study is designed to determine if the following are true. When protein requirements exceed metabolic requirements, blood urea nitrogen(BUN) levels will rise. Elevated BUN levels in the absence of renal failure, hepatic failure, or GI bleeding, will be correlated with improved nitrogen balance and inversely correlated with infection rates, days of mechanical ventilation, ICU days, and total hospital days.
Detailed description
The purpose of this study is threefold. First, to determine if a correlation exists between BUN and nitrogen balance in the context of hyperproteic nutrition administration. Creatinine clearance will also be followed to determine if there is any harmful effect to the kidney secondary to an elevated BUN. Secondly, to determine if there is a difference in hospital acquired infection rate, ventilator days, ICU days, and hospital stay between the current nutrition standard at Penn State Hershey Medical Center and a hyperproteic nutrition protocol. Thirdly, to determine the accuracy of at least three calculated creatinine clearance formulae when compared to a measured creatinine clearance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Nutrition | Active comparator | Behavioral: hyperproteic nutrition |
| Hyperprotein Nutrition | Experimental | Behavioral: hyperproteic nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Greater then or equal to 18 years of age and patient in Intensive Care Unit
- Receiving enteral nutrition, with expected duration of at least 5 days
- Blood urea nitrogen and creatinine clearance are part of routine blood work
- Indwelling urinary catheter in place
Key exclusion criteria (7 listed)
- Renal or hepatic failure
- Current or history(past 6 mos) of GI bleeding
- Serum creatinine on day of screening of equal to or greater then 1.5 mg/dl
- Creatinine Clearance on day of screening of equal to or less then 30ml/min
- Hypovolemia resulting in increased BUN
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 |
|---|---|---|
| hyperproteic nutrition | Behavioural | Hyperprotein Nutrition, Standard Nutrition |
Primary outcome
Increase in BUN
Time frame: Unable to document -incomplete information and investigator no longer at institution; no records available
1 secondary outcome
Decrease in infection rate, ventilator days, ICU stay and hospital dys
Time frame: Unable to document -incomplete information and investigator no longer at institution; no records available
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 1 Jun 2018.
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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.
John K Stene, MD principal investigator
Penn State University, College of Medicine, Dept of Anesthesiology
Questions about this trial
What is this clinical trial studying?
A study testing hyperproteic nutrition in people with Enteral Feeding, run by Milton S. Hershey Medical Center.
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 4 inclusion and 7 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 1 Jun 2018. 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.
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?
Increase in BUN (time frame: Unable to document -incomplete information and investigator no longer at institution; no records available). 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 1 Jun 2018.