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Completed

NCT Number: NCT00480259

Hyperproteic Nutrition:Correlation of BUN to Nitrogen Balance

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.

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Key information

Conditions

Enteral Feeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hyperproteic nutrition

Behavioral

Primary outcomes

  1. Increase in BUN

    Time frame: 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

    Time frame: Unable to document -incomplete information and investigator no longer at institution; no records available

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 30, 2007
Registry last updated
Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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