INTACT-HIP: INTravenous Acetaminophen vs. Oral Randomized Controlled Trial in HIP Fracture Patients - a Feasibility Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Trial feasibility-Comply study procedures
研究概览
简要总结
The INTACT-HIP trial study will evaluate feasibility of conducting a randomized, double-blinded controlled trial comparing postoperative treatment with intravenous (IV) acetaminophen versus oral acetaminophen, in older adults undergoing hip fracture surgery.
The results of this feasibility trial will be used to inform designing a larger, multi-center, randomized controlled trial to assess the efficacy of IV acetaminophen compared to oral acetaminophen to reduce delirium and improve other clinical and patient-centered outcomes after hip fracture surgery. It will randomize 42 older adults to receive either oral or IV acetaminophen after hip fracture surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple blinded
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 years of age and older
- •Patients who were ambulating without human assistance before fracture, with any type of non-neoplastic hip fracture
- •Patients undergoing surgical treatment as an inpatient
排除标准
- •Patients with neoplastic hip fracture
- •Severe cognitive impairment (Montreal Cognitive Assessment (MoCA) <10)
- •Pre-existing delirium
- •Known hypersensitivity or allergy to acetaminophen
- •Severe or chronic liver or kidney dysfunction
- •Planned postoperative ventilation
- •Swallowing issues and/or dysphagia
- •English language limitation
- •Weight <50kg
研究组 & 干预措施
Intravenous (IV) placebo plus oral acetaminophen
In this group the IV study drug will be normal saline and the pill will be acetaminophen
干预措施: Intravenous (IV) placebo plus oral acetaminophen (Drug)
Intravenous (IV) acetaminophen plus oral placebo
In this group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet.
干预措施: Intravenous (IV) acetaminophen + oral placebo (Drug)
结局指标
主要结局
Trial feasibility-Comply study procedures
时间窗: 30 days
Feasibility as assessed by failure to comply with study procedures. Failure to provide study drug at scheduled time will be documented.
Trial safety
时间窗: 30 days
Safety will be assessed as the number of participants experiencing intervention-related adverse or serious adverse events.
Trial feasibility-Recruitment
时间窗: 30 days
Feasibility as assessed by recruitment rate. This will be assesses as proportion of patients enrolled in the study compared to the number of patients meeting the inclusion/exclusion criteria.
Trial feasibility-Attrition
时间窗: 30 days
Feasibility as assessed by attrition rates. This will be defined as the proportion of patients completing the study at follow-up compared to the enrolled patients.
Trial feasibility-Availability of human resources
时间窗: 30 days
Feasibility as assessed by lack of availability of human resources). Inability to include patient in study due to lack of pharmacist or research assistant availability will be documented.
次要结局
- Delirium(On day of surgery, and days 1,2, 3 after surgery)
- Ambulation(Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery))
- Opioid consumption(Before surgery, on day of surgery, and days 1,2,3 after surgery)
- Overall health and disability(Baseline and at 30 days after surgery)
- Discharge location(At the time of discharge (at 1-3 days after surgery in most cases))
- Postoperative pain(Before surgery, on day of surgery, and days 1,2,3 after surgery)
- Cognitive dysfunction(Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery))
- Depression screen(Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery))
- Post-operative adverse events(On day of surgery, days 1,2, 3 after surgery, and at 30 days after surgery)
研究者
Jean Wong
Associate Professor, University of Toronto, Department of Anesthesiology and Pain Medicine
University Health Network, Toronto