ISRCTN17116445已完成未知
Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter-associated complications in adults living with long-term catheters
HS Grampian0 个研究点目标入组 80 人开始时间: 2019年11月6日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35927733/ (added 05/08/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged =18 years
- •2. Catheter has been in-situ for =28 days
- •3. No plan for discontinuation of LTC at the time of recruitment
- •4. Able to undertake catheter washouts or has a designated person able to perform washouts
- •5. Able to complete the trial documentation or has a proxy able to complete the trial documentation
- •6. Any type and route of LTC can be included
排除标准
- •Current participant exclusion criteria as of 22/04/2022:
- •1. Intermittent self-catheterisation
- •2. Pregnant or contemplating pregnancy
- •3. Spinal cord injury at or above the sixth thoracic vertebra (T6) (risk of Autonomic Dysreflexia - AD)
- •4. Ongoing S-CAUTI (until treatment is complete)
- •5. Visible hematuria (unless investigated/ treated)
- •6. Known allergies to either of the catheter washout solutions
- •7. Current bladder cancer (until treatment is complete and patient discharged from cancer surveillance program)
- •8. Known bladder stones (until treatment is complete)
- •9. Unable to provide consent due to incapacity
- •10. Any other clinical and social reasons that would be deemed by the recruitment team to be unsuitable for the study
- •If a participant stops using a long-term catheter (no catheter in situ) >=28 days. All data collected up to the point of stopping long term catheter use are retained and used in the analysis
- •Previous participant exclusion criteria:
- •1. Intermittent self-catheterisation
- •2. Pregnant or contemplating pregnancy
- •3. Spinal cord injury at or above the sixth thoracic vertebra (T6) (risk of Autonomic Dysreflexia - AD)
- •4. Ongoing S-CAUTI (until treatment is complete)
- •5. Visible hematuria (unless investigated/ treated)
- •6. Known allergies to either of the catheter washout solutions
- •7. Current bladder cancer (until treatment is complete and patient discharged from cancer surveillance program)
- •8. Known bladder stones (until treatment is complete)
- •9. Any other clinical and social reasons that would be deemed by the recruitment team to be unsuitable for the study
- •If a participant stops using a long-term catheter (no catheter in situ) >=28 days. All data collected up to the point of stopping long term catheter use are retained and used in the analysis
研究者
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