Evaluation of Novel Biomarkers in Early Recognition of Acute Kidney Injury After Orthopedic Operations.
研究概览
详细说明
Extensive orthopedic surgical procedures may have many postoperative complications. One of those, sometimes overlooked, is acute kidney injury. Classically defined by KDIGO criteria as an increase in creatinine concentration, may go by unnoticed due to a late peak in serum concentration of this marker. There is still need for "nephrological troponin" which could easily and with a low margin of doubt identify acute kidney injury.
The investigators have planned a double-center study, in cooperation with the 'Department of Anesthesiology and Intensive Therapy with the Postoperative Subdivision' of the 'Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP' in Otwock, concentrating on measuring concentration of biomarkers known to indicate acute kidney injury in different situations: Proenkephalin (PENK), Dickkopf-3 (DKK3), circular RNA (circRNA), Liver-type Fatty Acid-binding Protein (L-FABP), Netrin-1, semaphorin 3a, Tissue Inhibitor of Matrix Metalloproteinase-2 (TIMP-2), Insulin-like Growth Factor-binding Protein 7 (IGFBP-7), Retinol-binding Protein-4 (RBP-4) aiming to find a marker, or group of markers that would allow recognition of renal injury at an early stage to help minimize the effect.
Patients aged at least 18 years, with a hip fracture undergoing, either hip alloplasty, or internal fixation, after providing informed consent, will be included. Patients with end stage renal disease will be excluded. Blood and urine samples will be collected at 5 points of time: 1 - after admission to the operating ward, 2 - following surgery, before leaving the operating ward, 3 - on the 1st postoperative day, 4 - on the 2nd postoperative day, 5 - on the 5th postoperative day, or the day the patient leaves hospital, whichever is first. Additionally patients who will be able to cooperate will have a renal resistive index measured using ultrasonography.
Blood collected from patients, not longer than 8 hours after collection will be tested for PENK concentration (Spingotec GmbH, Berlin, Germany), then plasma obtained from this sample after centrifuging will be frozen together with centrifugated samples of urine in -80 degrees Celsius till analysis.
Additionally, if the concentration of PENK is elevated, the same sample will be tested after 8, 12 and 24 hours of staying at room temperature, to define stability of the test from blood sampling till measurement.
30 days after surgery, an attempt to contact the patient or his/her family is going to be made, to check if the patient has developed need for renal replacement therapy or has required hospitalisation due to kidney dysfunction together with a 30 day mortality evaluation.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Przemysław Bolewski
- 电话号码:0048225021721
- 邮箱:klinanest1@wum.edu.pl
学习地点
-
-
Mazowieckie
-
Otwock、Mazowieckie、波兰、05-400
- 招聘中
- Gruca Orthopaedic and Trauma Teaching Hospital
-
接触:
- Marek Janiak
-
Warsaw、Mazowieckie、波兰、02-005
- 招聘中
- I Department of Anesthesiology and Intensive Care Warsaw Medical University
-
接触:
- Marek Janiak, MD
- 电话号码:0048225021724
- 邮箱:klinanest1@wum.edu.pl
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- age at least 18 years
- be able to provide informed consent
Exclusion Criteria:
- end stage renal disease
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Any stage of acute kidney injury as defined by Kidney Diseases Improving Global Outcome
大体时间:120 hours
|
Concentration of novel biomarkers, its change and change of renal resistive index considering different stages of acute kidney injury
|
120 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Kidney perfusion evaluated by Renal Resistive Index (RRI)
大体时间:48 hours
|
Correlation between RRI and concentration of biomarkers
|
48 hours
|
|
Analysis of proenkephalin concentration
大体时间:24 hours
|
Change of proenkephalin concentration in the blood sample left at room temperature
|
24 hours
|
|
Kidney dysfunction and mortality
大体时间:30 days
|
Evaluation of 30-day need for renal replacement therapy, hospitalization due to kidney failure and/or mortality
|
30 days
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.