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临床试验/NCT01841138
NCT01841138已完成不适用

Changes of Serum Electrolytes During Bowel Prep With PEG 3350 + Ascorbic Acid - a Prospective Study

Klinik Bogenhausen1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2010年7月最近更新:
适应症

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

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

发起方
Klinik Bogenhausen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arne Schneider

PI

Klinik Bogenhausen

研究点 (1)

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