Does Osmolality of Oral Supplements Affect Stoma Output and Natriuresis in Patients With an Ileostomy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Stoma output
研究概览
简要总结
This double-blinded, active comparator, cross-over intervention study tested the impact of two different oral supplements on ileostomy output volume and urinary sodium excretion and intestinal aquaporin expression in eight compensated patients with an ileostomy and not on home parenteral Nutrition or fluid support.
详细描述
Patients with an ileostomy may experience fluid and electrolyte imbalances sedondary to an unregulated intestinal loss of water and electrolytes. The osmolality of oral supplements may affect these losses. In a double-blinded, active comparator, cross-over intervention study, the investigators test the effects of substituting 800 ml of the usual fluid intake with an intake of either an isoosmolar (300 mOsm/kg) or hyperosmolar (700 mOsm/kg) supplement during 48 hours, following baseline data collection before both intervention periods. Outcome measures were stoma output volume, 24-hour urine and urinary sodium excretion, and intestinal aquaporin 3 and 8 expressions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomisation by Third party; Unblinded study nurse to mix and deliver study product; masking of product to ensure comparable palatability and appearance; blinding to analyses
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 more
- •ilestomy established 6 weeks or more prior to inclusion
- •able to drink at least 100 ml fluid per 24 hours
- •i known inflammatory bowel disease, clinical remission judged by physician's global assessment (PGA)
- •less than 5 kg self-reported weight change during the past 3 months
排除标准
- •self-reported intolerance to dairy products, including lactose
- •known renal insufficiency, defined by an eGFR less than 30 ml/min
- •known diabetes mellitus, defined by an HbA1C > 48 mmol/mol (6.5%)
- •current enteral tube feeding or parenteral fluid or Nutrition support more than twice weekly
研究组 & 干预措施
Isoosmolar
Iso-osmolar oral supplement (276 mOsm/kg)
干预措施: Isoosmolar (Dietary Supplement)
Hyperosmolar
Hyper-osmolar oral supplement (681 mOsm/kg)
干预措施: Hyperosmolar (Dietary Supplement)
结局指标
主要结局
Stoma output
时间窗: 24 hours
24 hour stoma output weight
次要结局
- 24-hour urinary sodium excretion(24 hours)
- 24-hour urine production(24 hours)
研究者
Christian Hvas
MD PhD, associate professor
University of Aarhus