Pilot Randomized Trial of Intravenous or Oral Acetaminophen After Cardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Development of delirium post operatively
研究概览
简要总结
Double blind double dummy of Intravenous Acetaminophen and oral acetaminophen placebo versus IV placebo versus oral acetaminophen in patients following cardiac surgery. The primary endpoint is development of Delirium during the post-operative stay.
详细描述
The study is randomized, double-blinded, and multicentre. Enrollment includes patients 18 years or older who are going for aortocoronary bypass surgery, single valve, or bypass and single valve. The intervention is blinded IV acetaminophen and blinded oral active or placebo acetaminophen . The study will start with a pilot trial of 120 patients at 4 centers- 30 at each site, 15 per group. The pilot is a vanguard. If the pilot shows appropriate compliance with the protocol, reliable blinding and appropriate enrolment, the results will not be unblinded but rolled into the full study. Stratification will be by site and age < 60 or >= 60.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
blinded medication with codes kept in the pharmacy
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
- •subjects > 18 years of age undergoing elective aortocoronary bypass, single valve replacement or single valve and aortocoronary bypass surgery
排除标准
- •• Refusal by surgeon for inclusion of the patient
- •Requested late extubation by anesthesia or surgeon
- •Intra-aortic balloon pump
- •Sensitivity to acetaminophen
- •Pre-operative cognitive dysfunction
- •Psychiatric history with active treatment
- •Parkinson's disease
- •Alzheimer's disease
- •Medication for cognitive decline
- •History of recent seizures
- •Recent history of alcohol misuse
- •Creatinine clearance less than 30 ml/min
研究组 & 干预措施
Intravenous Acetaminophen
subjects will receive IV acetaminophen and a placebo oral acetaminophen starting immediately after surgery and for 8 doses
干预措施: acetaminophen (Drug)
Oral acetaminophen
subjects will receive a placebo for IV acetaminophen and active oral acetaminophen starting immediately after surgery and for 8 doses
干预措施: acetaminophen (Drug)
结局指标
主要结局
Development of delirium post operatively
时间窗: up to 7 days post operatively
Incidence of delirium will be analyzed between patients treated with IV or oral acetaminophen, measured from 24 hours post-operation and daily until discharge. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method (CAM) or CAMICU when in the intensive care unit
次要结局
- total opioid usage(up to 7 days post-operatively)
- Numeric pain rating scale(up to 48 hours)
- cognitive function(7 days post-operative, 6 months and 1 year)
- hospital length of stay(length of stay is measured from the day of surgery until the day of discharge from hospital in days)
- Intensive care length of stay(ICU stay is measured from the hour of arrival in the ICU and until the patient leaves the ICU in hours)
研究者
magder sheldon
Senior Physician
McGill University Health Centre/Research Institute of the McGill University Health Centre