The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for the Treatment of Pressure Ulcers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- percentage change in pressure ulcer area
研究概览
简要总结
To investigate whether an oral nutritional supplement of a mixture of arginine, glutamine and HMB for a maximum period of four weeks is more beneficial than the standard dietary approach to the healing of pressure ulcers, and to examine whether the use of it can reduce admissions and length of hospitalizations for these patients.
详细描述
All patients would be assessed by a dietitian to ensure them receiving nutritional support of at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method. During the study period, vitamin C and zinc supplement would not be given. Nutritional supplement other than that provided by the dietitian to meet the energy and protein requirement would not be given. The pressure ulcers would be cared according to the "Basic nursing standards for patient care: Wound dressing - Version 5" published by the Hospital Authority Head Office.
The treatment group would also be given 2 Sackets of a mixture of arginine, glutamine and HMB (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Inpatients of medical and geriatric wards of OLMH and WTSH
- •Aged 18 and older with stage III - IV lesions
- •Patients fed orally or through feeding tubes were included
排除标准
- •Patients with history of using the nutritional supplement (ABOUND) in previous three months
- •Patients with cellulitis, wounds with purulent discharge or osteomyelitis or sepsis
- •Patients requiring protein restriction
- •Patients with poorly controlled diabetes mellitus (latest HbA1C > 8.5) (healing process may be affected
- •Patients under palliative care
结局指标
主要结局
percentage change in pressure ulcer area
时间窗: 4 weeks
change in Pressure Ulcer Scale for Healing (PUSH)
时间窗: 4 weeks
次要结局
- length of hospitalisation(six months)
- number of hospital admissions(six months)
研究者
Lo Kwok Man
Associate Consultant
Our Lady of Maryknoll Hospital