Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT01274650
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT01274650
Study Brief:
Protocol Section:
NCT01274650