Use of a Hypercaloric and Hyperprotein Supplement Enriched with Immunonutrients in Multi-pathological Malnourished Patients to Improve the Incidence and Prevalence of Pressure Sores: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Risk of developing pressure-related injuries
研究概览
简要总结
The goal of this study is to evaluate the efficacy of a hypercaloric, hyperproteic enteral formula enriched with immunonutrients in preventing and treating pressure injuries in hospitalized malnourished patients.
Participants will take enteral formula (a complete hyperproteic and hypercaloric oral nutritional supplement with a fibre mixture enriched in omega 3, L-arginine and nucleotides, providing vitamin C and Zinc) or a hyperproteic and hypercaloric oral nutritional supplement with fibre mixture every day for 30 days.
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
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized chronic patients with complex needs in the Internal Medicine Department of a regional hospital.
- •Malnourished or at risk of malnutrition.
- •Moderate-high risk of developing pressure-related injuries or the presence of pressure-related injuries.
排除标准
- •Limitations in oral intake (due to pathologies, state of health, among others).
- •Contraindications for using the oral route and digestive intolerance or allergy to any of the components of the products.
研究组 & 干预措施
Intervention Group (Atémpero)
Participants received an arginine-enriched ONS called Atémpero®.
干预措施: Atémpero (Dietary Supplement)
Control Group
Participants received a complete high-protein, high-calorie diet with mixed fiber.
干预措施: Control (Standard treatment) (Dietary Supplement)
结局指标
主要结局
Risk of developing pressure-related injuries
时间窗: 15 and 30 days
Measurement instrument: Braden scale (low risk, moderate risk, high risk).
Presence of pressure-related injuries
时间窗: 15 and 30 days
Dichotomous variable: Yes/No.
Categorization of pressure-related injuries
时间窗: 15 and 30 days
Measurement instrument: PUSH scale (I, II, III, IV).
Pressure-related injuries healing
时间窗: 15 and 30 days
Measurement instrument: PUSH scale (closed, epithelial tissue, granulation tissue, sphacelium, necrotic tissue).
Degree of dependence
时间窗: 0, 15, and 30 days.
Measurement instruments (description): Barthel score (independent, mild, moderate, severe).
Weight loss
时间窗: 0, 15 and 30 days.
Measurement instruments (description): Weight scale (kg).
% of dietary intake
时间窗: 15 and 30 days.
0%, 25%, 50%, 75%, 100% intake.
ONS adherence
时间窗: 15 and 30 days.
0%, 25%, 50%, 75%, 100% intake.
次要结局
未报告次要终点
研究者
Antonio Jesús Marín Paz
Principal Investigator
University of Cadiz