The Renal Safety of Bowel Preparation With Polyethylene Glycol for Colonoscopy: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,237
- 试验地点
- 1
- 主要终点
- Number of Participants With Acute Renal Injury Which Included Acute Renal Dysfunction and Acute Kidney Injury
研究概览
简要总结
This study evaluates the changes of renal function after taking bowel cleansing agent polyethylene glycol for elective colonoscopy.
详细描述
Polyethylene glycol (PEG) is the most commonly used bowel cleansing agent for colonoscopy in the world.
PEGs are non-absorbable isosmotic solutions that pass through the bowel without net absorption or secretion. Significant fluid and electrolyte shifts are therefore attenuated.
However, several studies have shown that PEG may also impair renal function. One recent population-based study reported that the use of PEG was associated with an increased risk of acute kidney injury.
The renal safety of PEG in Taiwanese patient has not been reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 40 yrs of age or older scheduled for elective colonoscopy.
排除标准
- •Severely reduced kidney function (eGFR] <30 mL/min/1.73 m2)
- •Serum electrolyte abnormalities at screening
- •Uncontrolled congestive heart failure (American Heart Association Classification III or IV)
- •Unstable angina
- •Untreated dysrhythmia
- •Myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft surgery within the previous 3 months
- •Current acute exacerbation of chronic inflammatory bowel disease
- •Toxic colitis or toxic megacolon
- •Ileus and/or acute obstruction or perforation
- •Ileostomy
- •Right or transverse colostomy
- •Subtotal colectomy with ileosigmoidostomy
- •50% of colon removed
- •Idiopathic pseudo-obstruction
- •History of gastric stapling or bypass procedure
- •Difficulties swallowing
- •Treatment with an investigational drug or product
- •Participation in a drug study within 30 days prior to receiving study medication
- •Treatment with another bowel preparation within 21 days prior to colonoscopy
- •Known allergy or hypersensitivity to PEG solution
研究组 & 干预措施
Polyethylene glycol (PEG)
3-L polyethylene glycol (PEG) is provided for colonoscopy preparation. Patients receive blood tests for renal function and electrolytes before and after colonoscopy.
干预措施: Polyethylene glycol (PEG) (Drug)
结局指标
主要结局
Number of Participants With Acute Renal Injury Which Included Acute Renal Dysfunction and Acute Kidney Injury
时间窗: The durations between visits 1-2 and visits 2-3 were within 28 days, respectively. Patients with a ≥30% increase above the baseline serum creatinine levels during visit 2 or 3 were followed every 2-4 weeks until a peak level of creatinine was detected.
The screening visit (visit 1) induced a blood specimen for serum chemistry analysis. Immediately before the colonoscopy, study staff collected blood specimens for chemistry analysis (visit 2). The patients returned within 28 days after the colonoscopy for a final renal test (visit 3). Patients with a ≥30% increase above baseline creatinine levels during visit 2 or 3 were followed every 2-4 weeks until a peak level was detected (visit 4 and beyond).The serum creatinine level on visit 1 was recorded as the baseline renal function. The presence of renal injuries was determined by the highest serum creatinine level noted during the study period and included acute renal dysfunction, defined as a 30-49% increase above the baseline creatinine level, and acute kidney injury, defined as a ≥50% increase above the baseline serum creatinine. Number of participants with acute renal injury which included acute renal dysfunction and acute kidney injury will be recorded.
次要结局
- Number of Participants With Acute Electrolyte Disturbance (Including Serum Caclium, Phosphate, Sodium, Potassium, Chloride, and Magnesium).(The durations between visits 1-2 and visits 2-3 were within 28 days, respectively. Patients with electrolyte abnormalities during visit 2 or visit 3 were followed every 2-4 weeks until serum electrolyte values returned to normal.)
研究者
Chi-Liang Cheng
Assistant Professor
Evergreen General Hospital, Taiwan