NCT01299779已完成不适用
The Incidence of Hyponatremia With Two Commonly Prescribed Purgatives for Colonoscopy-Polyethylene Glycol 3350 With a Sports Drink (PEG-SD) Compared to Polyethylene Glycol 3350 With Electrolyte Solution (PEG-ELS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Development of hyponatremia in the peri-colonoscopy period
研究概览
简要总结
Objective: To compare the incidence of peri-colonoscopy hyponatremia associated with PEG 3350 + sports drink (PEG-SD) versus PEG 3350-electrolyte solution + sodium sulfate + sodium ascorbate and ascorbic acid (PEG-ELS).
Hypothesis: As compared to PEG-SD, hyponatremia occurs significantly less often with PEG-ELS.
详细描述
Looking at the Incidence of Hyponatremia With Two Commonly Prescribed Purgatives for Colonoscopy-Polyethylene Glycol 3350 With a Sports Drink (PEG-SD) Compared to Polyethylene Glycol 3350 With Electrolyte Solution (PEG-ELS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
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
- •Adults age 18 years or older scheduled for elective outpatient colonoscopy: 8am - noon.
排除标准
- •Unable or unwilling to consent
- •Breast feeding
- •Significant psychiatric illness
- •> 50% colon resection
- •Bowel obstruction
- •History of hyponatremia (Serum sodium <135 mmol/L)
- •End stage renal disease on dialysis
- •History of chronic kidney disease (other than kidney stones)
- •Decompensated cirrhosis, including:
- •History of bleeding due to portal hypertension (varices, gastropathy, etc) within 3 months
- •Hepatic encephalopathy (not controlled with medications) within 3 months
- •Clinical presence of ascites
- •Active cardiac disease
- •Recent myocardial infarction (<4weeks)
- •Unstable angina
- •Congestive heart failure NYHA Functional Class Stage III or IV
- •Stage III: Marked limitation of activity. Less than ordinary activity (e.g. walking short distances, 20-100 m) causes fatigue, palpitations, dyspnea. Comfortable at rest.
- •Stage IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
- •Exclusion Criteria (post-enrollment), from baseline labs:
- •Serum creatinine > 1.5 mg/dL
- •Serum potassium < 3.3 or > 5.5 mmol/L
- •Serum sodium < 135 mmol/L or >150 mmol/L
- •Serum calcium < 8.0 or > 11.0 mg/dL
研究组 & 干预措施
PEG-ELS
Active Comparator
干预措施: PEG-ELS (Drug)
PEG-SD
Active Comparator
干预措施: PEG-SD (Drug)
结局指标
主要结局
Development of hyponatremia in the peri-colonoscopy period
时间窗: blood drawn 30 minutes post colonoscopy
次要结局
- Development of serum electrolytes levels outside the normal range for(blood drawn 30 minutes post colonoscopy)
- Change from baseline for serum electrolytes(blood drawn 30 minutes post colonoscopy)
- Change in renal function from baseline(blood drawn pre colonoscopy and 30 minutes post colonoscopy)
- Changes in the following from baseline a. Serum vasopressin b. Serum osmolality c. Urine electrolytes and osmolality(blood drawn pre colonoscopy and 30 minutes post colonoscopy)
- Serum cortisol and TSH levels for only patients who develop hyponatremia(blood drawn 30 minutes post colonoscopy)
- Hemodynamic/volume changes at baseline and immediately prior to colonoscopy(hemodynamic measurments taken pre and post colonoscopy)
- Adverse Events - Incidence and severity using 10-point Likert scale(1 hour post colonoscopy assessment)
- Prep Completion: <90% vs. > 90%(one time assessment pre colonoscopy)
- Indication for colonoscopy: Screen/Surveillance vs. Symptom(one time assessment pre colonoscopy)
- Assessment of independent risk factors for hyponatremia(one time assessment pre colonoscopy)
- Efficacy(endoscopist will evaluate during colonoscopy)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
Fractional Urate Excretion in Nonedematous HyponatremiaCerebral HyponatremiaSIADHCerebral Salt-wasting SyndromeReset Hypothalamic OsmostatNCT01425125NYU Langone Health
终止
3 期
Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional HyponatremiaDilutional HyponatremiaInappropriate ADH SyndromeHyponatremiaNCT01227512Otsuka Pharmaceutical Development & Commercialization, Inc.124
尚未招募
4 期
A Prospective study of Hyponatremia in lower respiratory childreCTRI/2018/12/016534Goverment Medical college bhavnagar
招募中
不适用
Study of Clinical and Etiological Factors of Low Sodium in Body.CTRI/2017/06/008740SIR TAKHATSINHJI HOSPITA100
招募中
不适用
Impact of Peri-Operative Hyponatremia on Postoperative Outcomes in Major HPB Surgeries for CancersCarcinomaNCT06475911Institute of Liver and Biliary Sciences, India500