Hip Fracture Patient and the Use of IndwElling vs IntermittEnt Catheterization Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Study Feasibility - Follow-up
研究概览
简要总结
The primary aim of the proposed pilot feasibility is to determine whether it is feasible to recruit patients with a hip fracture into a prospective study and randomize them to either indwelling or intermittent catheterization. The study hypothesis is that the investigators would be able to show that this study can be incorporated into clinical practice, with satisfactory rate of patient recruitment and retention. Thus, the investigators would be able to compete this pilot study trial and proceed towards a multi-center trial.
详细描述
The primary aim of the proposed pilot feasibility is to determine whether it is feasible to recruit patients with a hip fracture into a prospective study and randomize them to either indwelling or intermittent catheterization.
The study hypothesis is that the investigators would be able to show that this study can be incorporated into clinical practice, with satisfactory rate of patient recruitment and retention. Thus, the investigators would be able to compete this vanguard trial and proceed towards a multi-center trial.
Secondary objectives would be related to safety and patient activity that would be important endpoints for the definitive, large scale trial. These would include the following:
- Is short term indwelling catheter use associated with reduced incidence of UTI compared to clean intermittent catheterization in patients with hip fracture.
- How does patient experience compare between these two forms of treatment?
Eligible patients will be approached for consent at admission and, if willing to participate, will be randomized into Group A or Group B using a web-based, computer-generated randomization with permuted blocks of varying sizes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
A clinical research coordinator that is blinded to the arm patients are randomized to will be responsible for recording all outcome measures of interest prospectively in the study's database from the patient's electronic medical records.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hip fracture (intertrochanteric, femoral neck, femoral head, sub-trochanteric) confirmed by imaging
- •Age ≥50 years
- •Operative treatment planned
- •Admitted under Orthopaedic Surgery
- •Willing and able to sign consent (substitute decision maker)
排除标准
- •Periprosthetic hip fracture
- •Polytrauma
- •Multiple fractures of the lower limbs
- •Previous lower urinary tract surgery
- •Known (past or current) urogenital cancer (prostate, bladder)
- •Urinary tract infection prior to randomization
- •Indwelling catheter present on admission (chronic or placed at previous acute setting)
结局指标
主要结局
Study Feasibility - Follow-up
时间窗: One year
Rates of participant follow-up
Study Feasibility - Retention
时间窗: One year
Participant retention rate in study
Study Feasibility - Enrollment
时间窗: One year
Number of participants enrolled and willingness of participants to be randomized Comparing the Number of patients screened compared to the number of patients meeting eligibility criteria. Tracking crossover between the treatment groups, participant retention, and follow-up rates.
Study Feasibility - Screening
时间窗: One year
Number of patients screened and number meeting eligibility
次要结局
- patient experience questionnaire(pre-operatively, and post-operative day six or at discharge)
- Safety-Related Outcomes - Rates of UTI(30 days)
- Safety-Related Outcomes - Rates of POUR(30 days)