跳至主要内容
临床试验/NCT00480259
NCT00480259已完成不适用

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

Milton S. Hershey Medical Center0 个研究点目标入组 8 人开始时间: 2007年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
主要终点
Increase in BUN

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Standard Nutrition

Active Comparator

干预措施: hyperproteic nutrition (Behavioral)

Hyperprotein Nutrition

Experimental

干预措施: hyperproteic nutrition (Behavioral)

结局指标

主要结局

Increase in BUN

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

相似试验