Frusemide Infusion for the Prevention of Deterioration of Renal Function in Post Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The incidence of increase in creatinine of 0.05 mmol/L or greater in the first 72 hours after cardiac surgery.
研究概览
简要总结
The purpose of the project is to test whether or not the commonly used medication frusemide, given after heart surgery, and aiming to increase urinary output can have an effect on kidney function.
详细描述
All patients will receive standard supportive care based on current established management practice of cardio-thoracic patients. The only difference in treatment will be the randomisation of patients to receive/not receive protocolised administration of frusemide targeting a urine output.
There will be 2 groups of patients. The control group-which will receive frusemide bolus doses if required as determined by the surgeon/consultant physician. The frusemide infusion group-which will be monitored to achieve a trial specified hourly urine output target range of 1-2mls/kg/hour. In order to achieve this target the patient may need to receive a loading dose of frusemide and may also then require a frusemide infusion. The aim will be to maintain the urine output within the target range for the first 48 hours after cardiac surgery.
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
- None
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
- •All patients admitted for cardiac surgery will be assessed for eligibility. Participants will be approached for inclusion, from the pre-admission clinics and wards of the Cardiothoracic surgery unit. Potential participants will be identified by the daily review of planned cardiothoracic surgery schedule.
排除标准
- •Already in established dialysis dependent chronic renal failure.
- •Known allergy to frusemide
- •Age < 18 years
研究组 & 干预措施
Standard Care
Patients will only receive frusemide as per the treating physicians treatment
干预措施: Frusemide (Drug)
Intervention
Patients will be given frusemide to achieve a study specified urine output target of 1-2mls/kg/hour
干预措施: Frusemide (Drug)
结局指标
主要结局
The incidence of increase in creatinine of 0.05 mmol/L or greater in the first 72 hours after cardiac surgery.
次要结局
- 3. Duration of post-operative hospital and ICU stay.
- 2. Incidence of renal failure requiring any form of renal replacement therapy.
- 4. The maximum Sequential Organ Failure Assessment (SOFA) score in the first 7 days of hospital stay.
- 1. The maximum change in serum creatinine from baseline value during the first 7 days of hospital stay.