Hyperproteic Nutrition:Correlation of BUN to Nitrogen Balance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00480259
Recruitment Status : Unknown
Verified May 2007 by Penn State University.
Recruitment status was:  Not yet recruiting
First Posted : May 30, 2007
Last Update Posted : May 30, 2007
Information provided by:
Penn State University

Brief 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 correlated with infection rates, days of mechanical ventilation, ICU days, and total hospital days.

Condition or disease Intervention/treatment Phase
Enteral Feeding Behavioral: hyperproteic nutrition Not Applicable

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 Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Hyperproteic Nutrition; Correlation of BUN to Nitrogen Balance and Associated Infection Rates With Bimodal Protein Administration

Primary Outcome Measures :
  1. Increase in BUN

Secondary Outcome Measures :
  1. Decrease in infection rate, ventilator days, ICU stay and hospital dys

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00480259

Sponsors and Collaborators
Penn State University
Principal Investigator: John K Stene, MD Penn State University, College of Medicine, Dept of Anesthesiology Identifier: NCT00480259     History of Changes
Other Study ID Numbers: 25351
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: May 30, 2007
Last Verified: May 2007

Keywords provided by Penn State University:
blood urea nitrogen
nitrogen balance
intensive care