Hyperproteic Nutrition:Correlation of BUN to Nitrogen Balance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hyperproteic Nutrition; Correlation of BUN to Nitrogen Balance and Associated Infection Rates With Bimodal Protein Administration

Conditions
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Enteral Feeding

Intervention / Treatment
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* Behavioral: hyperproteic nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Nutrition<br> | Behavioral: hyperproteic nutrition<br> <br> |
| Experimental: Hyperprotein Nutrition<br> | Behavioral: hyperproteic nutrition<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in BUN |  | Unable to document -incomplete information and investigator no longer at institution; no records available | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in infection rate, ventilator days, ICU stay and hospital dys |  | Unable to document -incomplete information and investigator no longer at institution; no records available | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood urea nitrogen, nitrogen balance, nutrition, intensive care