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临床试验/NCT01090076
NCT01090076已完成不适用

The Use of Specialised Amino Acid Mixture in Pressure Ulcer Wound Healing Rates-A Placebo Controlled Trial

Changi General Hospital2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
% Viable Tissue

研究概览

简要总结

This research aims to address the gap in the studies done and test the effects of a commercial mixture of 7 g of Arginine, 7 g Glutamine and 1.2 g HMB* twice a day on hard to heal pressure ulcers in an Asian patient cohort in an acute healthcare setting.

详细描述

Pressure ulcers are defined as areas of localised damage to the skin, muscle or underlying tissue, caused by shear, friction or unrelieved pressure, usually over bony prominences. They are associated with many health conditions that cause prolonged bed rest, immobility, inactivity or poor sensation and can significantly contribute to morbidity and mortality, particularly in the aged population. International prevalence rates range widely from 4.6%- 83.6% due to methodological differences and classification systems. In Singapore, a study on the prevalence of pressure ulcers in 3 hospitals revealed a prevalence of 9% to 14%.

Pressure ulcers often fail to heal in a timely and orderly manner, resulting in a chronic non-healing wound. Many intrinsic and extrinsic factors have been identified that can disrupt the wound healing processes of haemostasis, inflammation, proliferation, angiogenesis and remodelling. One of the factors gaining more interest for its impact on wound healing processes is nutritional status.

Arginine is a semi-essential amino acid because even though the body normally makes enough of it, supplementation is sometimes needed during critical illness and severe trauma. There have been numerous research studies focusing on using arginine to enhance wound healing and pressure ulcer prevention. It is required for promotion of nitrogen balance, cell proliferation, T lymphocyte function and collagen accumulation. It also changes into nitric oxide, which is known for its vasodilatory and angiogenic properties.

Glutamine is conditionally essential amino acid because it can be manufactured in the body, but under extreme physical stress the demand for glutamine exceeds the body's ability to make it. Adequate amounts of glutamine are generally obtained through diet alone because the body is also able to make glutamine on its own. Certain medical conditions, including injuries, surgery, infections, and prolonged stress, can deplete glutamine levels. Since glutamine plays a key role in the immune system, a deficiency in this nutrient can significantly slow the healing process.

Beta-hydroxy-Beta methylbutyrate (HMB) is a metabolite of leucine, an essential amino acid. HMB supplementation was associated with increased muscle mass accretion. HMB appears to assert its effect via inhibiting muscle proteolysis and modulating protein turnover.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients with pressure ulcers stage II, III or IV, non-healing admitted to Changi General Hospital for > 2 weeks
  • Patients who are able to attend outpatient follow-up appointments for dietary and wound review

排除标准

  • Age < 21 years old
  • Poorly controlled Diabetic Patients (HbA1c >7.0%)
  • Patients on Total Parenteral Nutrition
  • Patients in MICU/ SICU/ Medically Unstable/ Palliative Care
  • Patients with severe Sepsis
  • Length of stay < 2 weeks
  • Patients who require fluid restriction < 1L/d
  • Patients on any other wound healing supplements (e.g. Zinc, Vitamin A and Vitamin C)
  • Patients with lower extremity ulcers with untreated peripheral vascular disease
  • Patients with deep tissue infection and/or requiring debridement of necrotic or sloughy tissue
  • Patients unable to attend outpatient follow-up appointments
  • Patients who cannot tolerate oral intake > 70% EER and/or Fluid intake 30ml/kg BW
  • Patients who require protein restriction
  • Patients who are unable to give consent (absence of next-of-kin)

结局指标

主要结局

% Viable Tissue

时间窗: weeks 1 to 2

-Percentage viable tissue after 2 weeks The estimated change in proportion of viable and non-viable tissue was determined using area derived from planimetry via acetate tracings. The description of viable tissue was taken to mean granulating (red) or epithelising (pink) tissue, and non-viable tissue were taken as necrotic (black) or sloughy (green or yellow) tissue.

% Wound Area Week 1

时间窗: week 0 to 1

Percentage change in wound area after week 1

% Wound Area Week 2

时间窗: Weeks 1 to 2

Percentage change in wound area after week 2

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alvin Wong

Senior Dietitian

Changi General Hospital

研究点 (2)

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