Clinical Registry of Adverse Effects in the Preparation for Colonoscopy in Patients With Advanced Renal Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 237
- 试验地点
- 2
- 主要终点
- Global incidence of renal adverse effects (AEs)
研究概览
简要总结
Bowel preparation for colonoscopy requires the administration of large amounts of fluids that can cause fluid and electrolyte disturbances and volume overload, especially in patients with advanced renal failure. Polyethylene glycol-based regimens are considered safe, even in patients with advanced renal failure. However, the incidence of adverse effects (AEs) in routine clinical practice is unknown. The main objective of this study is to carry out a prospective, observational, multicenter clinical registry of renal AE of the preparation for colonoscopy, in patients with advanced renal failure, within the usual clinical practice of the preparation. Variables related to kidney function, bowel-cleansing efficacy, and tolerance will also be recorded. A segmented analysis will be performed in patients with substitutive renal therapy (hemodialysis or peritoneal dialysis).
详细描述
Introduction: Bowel preparation for colonoscopy requires the administration of large amounts of fluids that can cause fluid and electrolyte alterations and volume overload, especially in patients with advanced renal failure. Routine clinical practice of bowel preparation with polyethylene glycol-based regimens, including in patients with advanced renal failure, is considered safe. The hydroelectrolytic AEs and worsening of renal failure are generally mild and transient. However, the incidence of AEs in routine clinical practice is unknown, because there is no prospective record of the incidence of renal AEs in these patients.
Objectives:
- Principal. To carry out a clinical registry of the renal AEs of the preparation for colonoscopy, in patients with advanced renal failure, within the usual clinical practice of the preparation.
- Secondary:
- Study the efficacy of intestinal cleansing using the Boston bowel preparation scale.
- Study the patient-reported experience measures (PREMs) in terms of tolerability and acceptance of bowel preparation.
Study of the population and sample size: Outpatients with a scheduled colonoscopy for any indication and with moderate or severe renal impairment. Ages: 18-80, excluding partial colectomy, severe constipation, active intestinal disease, severe heart or liver failure, pregnancy or lactation, and refusal to authorize the clinical record of information. We calculated a sample size of 237 subjects to show an incidence of renal AD of 10%, with a precision of 4%.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients or hospitalized patients with previously scheduled colonoscopy with any indication: screening, follow-up or symptoms.
- •Diagnosis of stage 3B-5D chronic renal failure (creatinine clearance less than 45 ml / min / 1.73 m2).
排除标准
- •Age less than 18 years or greater than 80 years
- •Partial or total colectomy
- •Severe constipation
- •Active inflammatory bowel disease
- •Severe hepatic impairment (Child Pugh Classification C)
- •Pregnancy or breastfeeding
- •Refusal to authorize the clinical registration of the information
结局指标
主要结局
Global incidence of renal adverse effects (AEs)
时间窗: 3 hours to 7 days after laxative intake
Global incidence of renal adverse effects (AEs) (yes/no) if any of the following variables have an abnormal value in serum: sodium, potassium, calcium, chloride, bicarbonate, creatinine, or the glomerular filtrate rate calculated with the MDRD formula and the CKD-EPI formula.
次要结局
- Serum potasium concentration(3 hours to 7 days after laxative intake)
- Serum creatinine concentration(3 hours to 7 days after laxative intake)
- Adequate bowel cleansing for colonoscopy(At the moment of colonoscopy)
- Serum bicarbonate concentration(3 hours to 7 days after laxative intake)
- Serum phosphorus concentration(3 hours to 7 days after laxative intake)
- Need of urgent consultation(3 hours to 7 days after laxative intake)
- Serum sodium concentration(3 hours to 7 days after laxative intake)
- Serum ionized calcium concentration(3 hours to 7 days after laxative intake)
- Blood pH(3 hours to 7 days after laxative intake)
- Hemoglobin concentration(3 hours to 7 days after laxative intake)
- Adhrence to laxative intake(3-5 hours after laxative intake (at the colonoscopy appointment))
- Need of any drug treatment, new treatment or modification, that may affect kidney function or serum electrolytes(3 hours to 7 days after laxative intake)
- Glomerular filtration rate(3 hours to 7 days after laxative intake)
- Serum magnesium concentration(3 hours to 7 days after laxative intake)
- Blood platelets(3 hours to 7 days after laxative intake)
- Serum chloride concentration(3 hours to 7 days after laxative intake)
- Time from last intake of laxative to the colonoscopy(3-5 hours after laxative intake (at the colonoscopy appointment))
- Patient-reported experience measures (PREMs) questionnaire of laxative intake(3-5 hours after laxative intake (at the colonoscopy appointment))
- Early side effects of laxative intake(3-5 hours after laxative intake (at the colonoscopy appointment))
- Late side effects of laxative intake(3-7 days after laxative intake)
- Need for hospital admission(3 hours to 7 days after laxative intake)
研究者
Marco Antonio Alvarez Gonzalez
Principal Investigator
Parc de Salut Mar