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临床试验/NCT01274650
NCT01274650已完成不适用

Correlation Between Wound Volume and Depth of Decubitus Ulcers And Resting Energy Expenditure

Paul Edwards1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2010年9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
发起方
入组人数
25
试验地点
1
主要终点
Does the volume of decubitus ulcers have an effect on a patient's resting energy expenditure

研究概览

简要总结

Patient nutritional needs vary depending on several factors including age, sex, height, weight, injury and co-morbidities. Since injury affects energy expenditure in patients, this must be taken into account when assessing nutritional requirements. Indirect calorimetry will be used to measure energy expenditure of patients with decubitus ulcers of varying degrees. The primary objective of this study is to determine the effects of wound volume on metabolic rate and compare this to predictive equations used for estimating energy requirements.

详细描述

Adequate nutrition is an important aspect of wound healing because it provides an anabolic environment necessary for tissue repair. Without proper nutrition support, healing can be prolonged and even inhibited. Provision of adequate energy is essential in patients with decubitus ulcers to maximize nitrogen retention and facilitate wound healing. (1,2) There are few published studies that measure energy needs in patients with decubitus ulcers. Spinal cord injured patients are one of the few populations where studies have utilized indirect calorimetry to measure energy expenditure. Individuals with spinal cord injuries are particularly at risk for developing pressure ulcers. Liu, et al. (3) measured energy expenditure in 16 individuals with quadriplegia and pressure ulcers and in 16 individuals with quadriplegia but no pressure ulcers. Measured energy expenditure was significantly higher in subjects with quadriplegia and pressure ulcers. Additionally, pressure ulcer surface area was significantly correlated with predicted resting energy expenditure. In a study of paraplegic individuals, Alexander, et al. (4) found resting metabolic rate was significantly higher in those individuals with pressure ulcers compared to those with paraplegia without pressure ulcers. Additional research is needed to confirm these findings.

To determine nutrition requirements specific to each patient, energy needs must be estimated, taking into account weight, height, age, activity level as well as the size of the wound and the patient's co-morbidities. Although indirect calorimetry is the gold standard for measuring metabolic rate, it is impractical and time consuming to use this method to determine needs of every patient. Therefore, the clinician uses predictive formulas for estimating energy needs. The most commonly cited guideline for energy requirements for healing pressure ulcers is 30-35 kcal/kg (recommendation, National Pressure Ulcer Advisory Panel).(1) The European Pressure Ulcer Advisory Panel has also recommended a minimum of 30-35 kcal/kg.(2) Several equations have been derived to predict metabolic rate based on age, height, weight, and sex. Two of these predictive equations are the Harris Benedict (5) and the Mifflin-St. Jeor. (6) These equations can be adjusted for injury factors, but it is unclear if they fully account for the size of wound in patients with decubiti.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Admitted to the Saint Elizabeth Regional Burn and Wound Center
  • •Ulcer located in the Ischial, Sacral, Coccyx

排除标准

  • •Patient Has Signs of Infection
  • •Patient is receiving oxandrolone treatment or anabolic hormone treatment
  • •Is Patients receiving intermittent tube feedings

研究组 & 干预措施

Decubitis Ulcer

Other

Patients admitted to the hospital with decubitus ulcers in the ischial, sacral, or coccyx area.

干预措施: Indirect Calorimetry (Procedure)

结局指标

主要结局

Does the volume of decubitus ulcers have an effect on a patient's resting energy expenditure

时间窗: 1 year

Data obtained in this study will be analyzed using methods that enable a description of the patient population and a comparison of the results against previously formulated equations for energy expenditure. Descriptive summaries will be presented for demographic and clinical background variables, study objectives, and outcome variables and safety endpoint

次要结局

未报告次要终点

研究者

发起方
Paul Edwards
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Paul Edwards

Research Coordinator

Saint Elizabeth Regional Medical Center

研究点 (1)

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