Efficacy and Safety of Ascorbic Acid in Prevention of Catheter Associated Urinary Tract Infections in Institutionalized Patients Undergoing Elective General Surgery - A Double Blinded Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Incidence of catheter associated urinary tract infections in patients undergoing elective
研究概览
简要总结
The study is a double blinded randomized controlled study where group A and B would be treated with ascorbic acid and placebo respectively. The urine samples would be collected on multiple occasions including the preoperative screening. The samples would thereafter be taken on the day of catheterization, 48 hrs post-catheterization, foley tip culture on day of removal, 48 hours post removal of catheter and 1 week post removal of catheter. Any single positive urine culture would be classified as CAUTI and thereafter at the end of study, data would be analysed to compare CAUTI between the two groups as the primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective general surgery Patients with negative pre-catheterization urine culture.
排除标准
- •Patients with mental disorders or illness who cannot understand or comply with the study protocol Patients with known drug allergy/contraindications to ascorbic acid Patients on antimicrobials Any patients with difficult catheterization.
结局指标
主要结局
Incidence of catheter associated urinary tract infections in patients undergoing elective
时间窗: Catheterization to 10 days post catheter removal
general surgery
时间窗: Catheterization to 10 days post catheter removal
次要结局
- Treatment emergent adverse effects (TEAE)(Catheterization to 10 days post catheter removal)
- Incidence of urosepsis as defined by SIRS criteria(Catheterization to 10 days post catheter removal)
- Complications of CAUTI and per urethral catheterization as per modified(Clavien-Classification system)
研究者
Dr Navya Thakur
University college of medical sciences and Guru Teg Bahadur Hospital