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Hyperproteic Nutrition:Correlation of BUN to Nitrogen Balance

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ClinicalTrials.gov Identifier: NCT00480259
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Milton S. Hershey Medical Center

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)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hyperproteic Nutrition; Correlation of BUN to Nitrogen Balance and Associated Infection Rates With Bimodal Protein Administration
Actual Study Start Date : June 1, 2007
Actual Primary Completion Date : April 21, 2009
Actual Study Completion Date : April 21, 2009

Arm Intervention/treatment
Active Comparator: Standard Nutrition Behavioral: hyperproteic nutrition
Experimental: Hyperprotein Nutrition Behavioral: hyperproteic nutrition



Primary Outcome Measures :
  1. Increase in BUN [ Time Frame: Unable to document -incomplete information and investigator no longer at institution; no records available ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00480259


Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: John K Stene, MD Penn State University, College of Medicine, Dept of Anesthesiology

Responsible Party: Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00480259     History of Changes
Other Study ID Numbers: 25351
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

Keywords provided by Milton S. Hershey Medical Center:
blood urea nitrogen
nitrogen balance
nutrition
intensive care