Myocardial Injury After Radical Nephrectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of patients undergoing radical nephrectomy with evidence of myocardial injury (MINS)
研究概览
简要总结
Kidney removal for cancer (nephrectomy) is a major operation. People can develop heart complications during or after surgery, especially if they are older or already have heart disease. One form of heart damage is called myocardial injury (MINS). This can be detected with a simple and easily available blood test. Unlike a heart attack, MINS doesn't cause changes in the electrical tracing of the heart (ECG) and it typically doesn't cause symptoms like pain. However, it can lead to heart problems and a stroke after surgery. We do not know how many people having a nephrectomy develop MINS. It is important to know if people are at high risk of MINS to help decide future treatment.
There are a few different ways of carrying out nephrectomy surgery. These can be traditional open surgery, keyhole surgery or robotic surgery. We know that MINS is more likely if there has been a lot of bleeding during the operation, but other factors are also important. Therefore, it's important to monitor the relationship between blood loss, rates of MINS and method of surgery.
We aim to recruit 120 participants undergoing nephrectomy to see how many develop MINS and to compare blood loss between different ways of surgery. Patients will be asked to consent to have blood tests on the day of and the day after surgery. This test will be added to routine hospital blood tests (and so no extra samples are needed). These results will show how many patients are diagnosed with MINS after nephrectomy. Around 90 days after the surgery, their quality of life and any further heart or breathing problems will also be recorded.
We hope to identify the rates of and risk factors for MINS, so future patients can be spared this complication of surgery.
详细描述
Patients undergoing nephrectomy have a greater risk of cardiac events requiring admission compared to the general population. For example, registry data report 21% of patients over 65 undergoing nephrectomy have at least one cardiovascular event after surgery. Myocardial injury after non-cardiac surgery (MINS) is a condition which is associated with increased mortality and a higher rate of major adverse cardiac events (MACE), in both the immediate perioperative period and within 1-year post-surgery. Diagnosis is via the presence of elevated troponin levels in the first 3 days post-surgery, in the absence of ischaemic symptoms and ECG changes.
The occurrence of MINS following nephrectomy for renal cell carcinoma has not yet been explored. Risk factors for MINS include increasing age and post-operative acute kidney injury. Results from the British Association of Urological Surgeons (BAUS) Nephrectomy audit demonstrate that most patients undergoing nephrectomy are over 60 and that increasing age is associated with lower eGFR pre-operatively. The accepted further reduction in post-operative GFR with nephrectomy makes these patients at high risk of MINS.
The BAUS Nephrectomy audit also demonstrates that elderly patients undergoing nephrectomy are likely to be anaemic preoperatively. In at-risk patients, any intraoperative haemodynamic instability may progress to myocardial injury and cardiac related complications due to a change in myocardial oxygen demand.
Most radical nephrectomies are now performed using robotic or laparoscopic approaches. Current evidence from retrospective studies and a small prospective study suggests that there is no difference in perioperative nor oncological outcomes between laparoscopic and robotic radical nephrectomy, including blood loss. However, no studies to date have looked at MINS and large-scale prospective studies comparing the haemodynamic effects of laparoscopic vs robotic nephrectomy are needed.
Understanding the spectrum of MINS and its potential impact on patients undergoing nephrectomy is pivotal. This could lead to better patient selection and stratified care to improve outcomes. Advances in systemic therapy for metastatic disease mean nephrectomy may become more prevalent in persons on multiple therapies. As patients undergoing nephrectomy are at high risk of MINS, it is vital to have a greater understanding of this potential complication. This aligns with the James Lind Alliance Priority Setting Partnership in perioperative care which highlights the importance of research into post-operative complications. Furthermore, this group also underlines the importance of adequate preoperative discussions with patients, which would include the risk of postoperative complications such as MINS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of patients undergoing radical nephrectomy with evidence of myocardial injury (MINS)
时间窗: 72 hours post surgery
This will be defined as a raised troponin level \>99th percentile upper reference limit on any sample taken within 72 hours following the operation.
次要结局
- Occurrence of intraoperative and post-operative blood transfusion(72 hours post surgery)
- Impact on quality of life, assessed by EQ-5D-5L questionnaire completed by patients(90 days post surgery)
- Rate of major adverse cardiac events (MACE)(90 days post surgery)
- Number of days out of hospital(90 days post surgery)
