Changes of Serum Electrolytes During Bowel Prep With PEG 3350 + Ascorbic Acid - a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Proportion of patients with serum sodium concentration beyond the limits of normal after the completion of bowel preparation
研究概览
简要总结
Hypothesis: Patients who undergo bowel preparation with PEG 3350 + ascorbic acid may have significant changes of serum electrolytes.
A new PEG solution (Moviprep = PEG 3350 + ascorbic acid) for colonoscopy reduces the amount of cathartic solution to 2 liters, but requires drinking of additional liquid for optimal results. Ingestion of a high volume of free water bears a risk for severe changes of serum electrolytes, particularly for sodium and potassium.
In this trial, patients undergo regular bowel preparation for standard colonoscopy with Moviprep (2 liters Moviprep split-dose plus ≥2 liters of free liquid until sufficient cleansing is achieved). Blood samples for serum sodium, potassium, chloride, magnesium, phosphate, calcium and serum osmolarity are taken before the beginning of the prep procedure and right before colonoscopy. The interval between both blood samples that will be compared is roughly 24 hours. Additionally, the volume of prep solution and additional liquid is recorded. The quality of bowel preparation is visually rated during colonoscopy with a validated score.
Pre- and postpreparation serum parameters will be compared. Primary outcome measure is the proportion of patients who have a serum sodium beyond the reference values after the completion of bowel preparation. Secondary outcome parameters are the proportion of patients with other serum electrolytes or serum osmolarity beyond the reference. Moreover, changes of serum electrolytes and osmolarity will be correlated with the amount of prep solution and liquid.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •indication for colonoscopy
- •>=18 years
排除标准
- •<18 years
- •acute inflammatory bowel disease
- •previous bowel resection
- •high-grade cardiac or renal insufficiency
结局指标
主要结局
Proportion of patients with serum sodium concentration beyond the limits of normal after the completion of bowel preparation
时间窗: within 2 hours before the beginning of colonoscopy
次要结局
- Proportion of patients with serum potassium or calcium or chloride or magnesium concentration beyond the limits of normal after the completion of bowel preparation(within 2 hours before the beginning of colonoscopy)
研究者
Arne Schneider
PI
Klinik Bogenhausen
