Preoperative Prediction of Acute Kidney Injury After Cardiac Surgery (RFR)
2017年3月27日 更新者:Faeq Husain、University of Giessen
Use of Preoperative Renal Functional Reserve to Predict Risk of Acute Kidney Injury After Cardiac Surgery
Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to determine AKI risk are lacking.
Renal functional reserve (RFR), the capacity of the intact nephron mass to increase glomerular filtration rate (GFR), represents maximal filtration capacity.
We hypothesized that preoperative RFR would predict postoperative AKI.
研究概览
详细说明
Acute kidney injury (AKI) is a frequent complication in patients undergoing cardiac surgery with an estimated prevalence of 36%.
However, clinicians have limited tools to preoperatively identify patients at risk for AKI and/or progression to chronic kidney disease, particularly in patients with normal resting glomerular filtration rate (rGFR).
Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase GFR from baseline in response to stimuli (e.g., protein load).
We hypothesized that the presence or absence of RFR could separate patients at risk for developing AKI from patients with better-preserved renal function and a more favorable short- and long-term prognosis despite identical rGFR.
The aim of this study is to examine whether preoperative assessment of RFR is able to predict risk for AKI after cardiac surgery.
研究类型
观察性的
注册 (实际的)
110
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Adult patients undergoing elective cardiac surgery
描述
Inclusion Criteria:
- Subjects older than 18 years
- Subjects undergoing elective cardiac surgery
- Subjects who signed informed consent forms
Exclusion Criteria:
- Pregnancy
- Chronic kidney disease ≥ stage III
- Solitary kidney
- Diabetes mellitus type 1
- Recent cardiac arrest
- Liver failure or cirrhosis
- Total parenteral nutrition
- Hemoglobin <11 g/dl
- Sepsis
- History of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency
- Transplant donor or recipient
- Active autoimmune disease with renal involvement
- Rhabdomyolysis
- Prostate hypertrophy with International Prostate Symptom Score ≥20
- Neoplasm
Withdrawal criteria:
All patients included in the study were to be followed up until the scheduled end of the study. Data collection could be terminated prior to the scheduled time only under the following conditions:
General criteria
- A patient or his/her legal representative may refuse further participation in the study at any time (withdrawal of consent),
The investigator may withdraw a patient from the participation in the study at any time for the following reasons:
- a severe protocol violation,
- the development of incidents/near-incidents/other severe clinical complications related to the study protocol
Criteria related to the study
- Subjects who could not stop taking angiotensin-converting enzyme inhibitors and/or angiotensin II receptor blockers a minimum of 48 hours before the protein load.
- Subjects who received non-steroidal anti-inflammatory drugs within the 48 hours before the protein load.
- Subjects who received intravenous radiocontrast agents within the 72 hours before the protein load.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
The predictive value of RFR for AKI in patients undergoing elective cardiac surgery
大体时间:1 day before cardiac surgery
|
1 day before cardiac surgery
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Whether the occurrence of AKI (as defined by Kidney Disease Improving Global Outcomes criteria) impacts RFR three months after surgery in patients without ongoing reduced function defined by resting GFR
大体时间:3 months after cardiac surgery
|
3 months after cardiac surgery
|
Whether urinary [TIMP-2][IGFBP7] predicts loss of RFR
大体时间:3 months after cardiac surgery
|
3 months after cardiac surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Claudio Ronco, MD、International Renal Research Institute of Vicenza
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Sharma A, Zaragoza JJ, Villa G, Ribeiro LC, Lu R, Sartori M, Faggiana E, de Cal M, Virzi GM, Corradi V, Brocca A, Husain-Syed F, Brendolan A, Ronco C. Optimizing a kidney stress test to evaluate renal functional reserve. Clin Nephrol. 2016 Jul;86(7):18-26. doi: 10.5414/CN108497.
- Haase M, Kellum JA, Ronco C. Subclinical AKI--an emerging syndrome with important consequences. Nat Rev Nephrol. 2012 Dec;8(12):735-9. doi: 10.1038/nrneph.2012.197. Epub 2012 Sep 25.
- Ronco C, Chawla LS. Glomerular and Tubular Kidney Stress Test: New Tools for a Deeper Evaluation of Kidney Function. Nephron. 2016;134(3):191-194. doi: 10.1159/000449235. Epub 2016 Aug 30.
- Husain-Syed F, Emlet DR, Wilhelm J, Danesi TH, Ferrari F, Bezerra P, Lopez-Giacoman S, Villa G, Tello K, Birk HW, Seeger W, Giavarina D, Salvador L, Fuhrman DY, Kellum JA, Ronco C; IRRIV-AKI Study Group. Effects of preoperative high-oral protein loading on short- and long-term renal outcomes following cardiac surgery: a cohort study. J Transl Med. 2022 May 10;20(1):204. doi: 10.1186/s12967-022-03410-x.
- Husain-Syed F, Ferrari F, Sharma A, Hinna Danesi T, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanella M, Brendolan A, Giavarina D, Salvador L, Bellomo R, Rosner MH, Kellum JA, Ronco C. Persistent decrease of renal functional reserve in patients after cardiac surgery-associated acute kidney injury despite clinical recovery. Nephrol Dial Transplant. 2019 Feb 1;34(2):308-317. doi: 10.1093/ndt/gfy227.
- Husain-Syed F, Ferrari F, Sharma A, Danesi TH, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanella M, Brendolan A, Giavarina D, Salvador L, Bellomo R, Rosner MH, Kellum JA, Ronco C. Preoperative Renal Functional Reserve Predicts Risk of Acute Kidney Injury After Cardiac Operation. Ann Thorac Surg. 2018 Apr;105(4):1094-1101. doi: 10.1016/j.athoracsur.2017.12.034. Epub 2018 Jan 31.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年11月1日
初级完成 (实际的)
2015年10月31日
研究完成 (实际的)
2016年2月28日
研究注册日期
首次提交
2017年3月21日
首先提交符合 QC 标准的
2017年3月21日
首次发布 (实际的)
2017年3月28日
研究记录更新
最后更新发布 (实际的)
2017年3月29日
上次提交的符合 QC 标准的更新
2017年3月27日
最后验证
2017年3月1日
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.
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