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Hyperproteic Nutrition:Correlation of BUN to Nitrogen Balance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Penn State University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00480259
First received: May 29, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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 Intervention
Enteral Feeding
 Behavioral: hyperproteic nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Hyperproteic Nutrition; Correlation of BUN to Nitrogen Balance and Associated Infection Rates With Bimodal Protein Administration

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Increase in BUN

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480259

Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: John K Stene, MD Penn State University, College of Medicine, Dept of Anesthesiology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00480259     History of Changes
Other Study ID Numbers: 25351
Study First Received: May 29, 2007
Last Updated: May 29, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013