Goldilocks' Zone: Optimised Osmolality in Supplements for the Patient With an Ileostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- ileostomy output
研究概览
简要总结
Quasi-randomized, crossover intervention study, testing osmolality in oral drinks and effect on 6-hours ileostomy output in adult patients with an ileostomy
详细描述
14 patients with ileostomies were included in a quasi-randomized, crossover intervention study. Each patient ingested between 3-18 different supplements during separate 6-hours intervention periods. Ileostomy output and urine volume will be collected. Outcome measures include faecal wet-weight, urine volume, electrolytes, osmolality, and body composition measured with bioelectrical impedance analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The patients were randomised to receive either the hypo-osmolar or hyper-osmolar in their first intervention. Microsoft Excel feature "RAND" (Microsoft version 16) was used to randomize oral supplements. Each supplement was assigned a number. Every time a patient agreed to one or two more intervention periods, two supplements were randomized. One of the primary investigators (JQ) enrolled and randomized supplements to the patients
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
- •age 18 years or higher
- •ileostomy formed at least 8 weeks before enrolment
- •consent to participate
排除标准
- •known chronic kidney disease
- •known diabetes mellitus
- •too long driving distance
- •parenteral nutrition/fluid more than 6 litres per month
研究组 & 干预措施
isoosmolar
one with an iso-osmolar fluid
干预措施: semi skimmed milk or powerade (Dietary Supplement)
hyperosmolar
one with a hyper-osmolar
干预措施: juice (Dietary Supplement)
hypoosmolar
One with a hypo-osmolar fluid
干预措施: water (Dietary Supplement)
结局指标
主要结局
ileostomy output
时间窗: 6 hours
ileostomy output (wet weight feces grams)
次要结局
- natriuresis(6 hours)
- urine sodium(6 hours)
- urine osmolality(6 hours)