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临床试验/NCT03092947
NCT03092947已完成不适用

Use of Preoperative Renal Functional Reserve to Predict Risk of Acute Kidney Injury After Cardiac Surgery

University of Giessen0 个研究点目标入组 110 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
主要终点
The predictive value of RFR for AKI in patients undergoing elective cardiac surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjects older than 18 years
  • Subjects undergoing elective cardiac surgery
  • Subjects who signed informed consent forms

排除标准

  • 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
  • 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
  • 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.

结局指标

主要结局

The predictive value of RFR for AKI in patients undergoing elective cardiac surgery

时间窗: 1 day before cardiac surgery

次要结局

  • 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(3 months after cardiac surgery)
  • Whether urinary [TIMP-2][IGFBP7] predicts loss of RFR(3 months after cardiac surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Faeq Husain

Senior Physician

University of Giessen

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