Effect of IV Alanyl Glutamine on Healing of Pressure Ulcers in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage change in pressure ulcer length
研究概览
简要总结
In this clinical trial, we will assess pressure ulcer healing rates in critically ill patients supplemented with IV Alanyl-Glutamine in comparison with critically ill patients not supplemented with alanyl-glutamine.
详细描述
This clinical trial will include 200 Egyptian Critically ill patients with bed sores equal or more than grade II selected from ward or ICU at Air Force specialized Hospital. They will be classified into 2 groups:
- Group I: 100 critically ill patients will be enrolled on high protein diet and receiving IV alanyl Glutamine with dose 0.3 gm/kg/ day which equal 1.5 ml/kg/day of alanyl-glutamine until discharge from ICU, death (with duration of 2 weeks administration).
- Group II: 100 critically ill patients will be enrolled on high protein diet either enteral or parenteral but not receiving any glutamine supplementations.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pressure ulcers stage 2,3 or 4, non-healing admitted to Air force specialized hospital for more than a week.
排除标准
- •Patients with renal impairment (GFR </= 30)
- •Patients who require fluid restriction < 1 Litre/day.
- •Patients with liver cirrhosis. (Child B and C)
- •Length of stay< 2 weeks.
- •Patients with deep tissue infection and/or requiring debridement of necrotic or sloughy tissue.
- •Hemodynamically unstable patients. (On high dose of cardiac supports)
结局指标
主要结局
Percentage change in pressure ulcer length
时间窗: 2 weeks
Final ulcer length/original ulcer length x 100
Percentage change in pressure ulcer depth
时间窗: 2 weeks
Final ulcer depth/original ulcer depth x 100
Percentage change in proportion of viable wound tissue
时间窗: 2 weeks
Final proportion of viable wound tissue /original proportion of viable wound tissue x 100
Percentage change in pressure ulcer area
时间窗: 2 weeks
Final ulcer area/original ulcer area x 100
次要结局
未报告次要终点