A Randomized, Prospective, Controlled, Double-blind, Single-center Pilot Study in Critically Ill Patients Investigating Tolerability and Efficacy of Low-volume Pharmaconutrition (Intestamin)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Length of stay in ICU
研究概览
简要总结
The aim of the study is to assess the efficacy and tolerability of the low-volume supplement. The investigators randomized critically ill patients to receive Intestamin plus Fresubin or Fresubin alone.
详细描述
To compare early supplementation with antioxidants and glutamine using an enteral pharmaconutrition supplement (Intestamin®) to an energy adjusted standard elementary diet and to investigate its affect on clinical efficacy and tolerability in critically ill patients with sepsis/SIRS.
Methods: This was a prospective controlled randomized study in 58 critically ill patients. They received either Intestamin or a diluted Fresubin solution. After 10 or 14 days inflammatory parameters, catecholamine need, and maximal enteral delivery were determined.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sepsis or SIRS (APACHE score 10-30),
- •no severe gastrointestinal tract or metabolic diseases,
- •enteral feeding within 48 h of admission,
- •age 18-75 years,
- •written consent by patient or next of kin. -
排除标准
- •participation in a drug trial within the last 4 weeks before inclusion in this study,
- •previous participation in this study,
- •expected patient survival of less than 6 days,
- •pregnancy or lactation,
- •patients with unstable vital signs that would probably cause incidents that would make participation impossible or would lead to discontinuation,
- •severe liver disease with cytolysis (ASAT >10 N) or impaired detoxification (ammonia >50 mmol/L, bilirubin > 50 μmol/L),
- •gastrointestinal surgery in the last 4 weeks,
- •severe enteritis/colitis,
- •short intestine syndrome,
- •gastrointestinal bleeding that requires intervention,
- •patients who could not be enterally fed
研究组 & 干预措施
Intestamin plus Fresubin Original
干预措施: Intestamin plus Fresubin Original (Dietary Supplement)
Fresubin Original
干预措施: Fresubin Original (Dietary Supplement)
结局指标
主要结局
Length of stay in ICU
时间窗: 14 days
The primary endpoints were length of stay in ICU and sufficient enteral feed.
次要结局
- mortality(14 days)