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临床试验/NCT02900313
NCT02900313已完成不适用

Predictive Interest of Serum Phosphorus Level in the Early Diagnosis of Acute Renal Insufficiency in Post-operative Immediate at Patients Having Benefited From a Cardiac Surgery.

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
264
试验地点
2
主要终点
Dosage of phosphorus

研究概览

简要总结

Cardiac surgery associated acute kidney injury is an independent factor of morbidity and mortality . Despite its delayed elevation, serum creatinine (Cr) remains the goal standard to diagnose AKI. Hyperphosphatemia is well-know in case of AKI because of its excretion decrease. Moreover, serum phosphorus (Ph) is daily measure d after cardiac surgery since its variation may lead to cardiac dysfunction. In case of AKI, Ph may reflect the decrease of renal function in this context. Consequently, the purpose of this study is to evaluate the predictibility of Ph to detect both AKI induction and in a second time, renal recovery.

详细描述

It is a one-year prospective diagnostic validation study included all patients > 18 years-odl admitted in our center after cardiac surgery. AKI is define according to KDIGO criteria and classified in the groups of severity according to the Cr elevation and the need of renal replacement therapy. Serum Cr and Ph are measured at baseline before surgery , at ICU admission, every 12 hours until ICU discharge and every 24 hours until hospital discharge. To evaluate the predictability of Of Ph to diagnose AKI, the postoperative Ph percentage of maximal elevation (%EPh) will be calculated. Then the diagnostic performance of %EPh wil be assessed by calculating the areas under the Receiver Operating Characteristic Curve (AUC) to determine an optimal threshold with sensibility, specificity, positive predictive value and negative predictive value.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • All the patients who are more than 18 years having cardiac surgery and having benefited from a dosage of serum phosphorus level and serum creatinine during all the duration of the hospitalisation

排除标准

  • Chronic renal insufficiency with a glomerular filtration rate = 15ml / min / 1.73m2
  • Chronic Renal insufficiency dialysed
  • History of single kidney or nephrectomy
  • Vulnerable people according to the article L1121-6 of the public health Code
  • Protected adult or in the incapacity to give his consent according to the article L1121-8 of the public health Code
  • The patient present formalizes his opposition for the continuation of the study
  • Pregnant or breast-feeding Women according to the article L1121-5 of the Public health Code

研究组 & 干预措施

Patients having cardiac surgery

Other

Cohort of patients who are more than 18 years having cardiac surgery and having benefited from a dosage of serum phosphorus level and serum creatinine during all the duration of the hospitalisation

干预措施: cardiac surgery (Other)

结局指标

主要结局

Dosage of phosphorus

时间窗: 48 hour after cardiac surgery

Kinetic phosphorus during acute renal failure in postoperative cardiac surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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