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临床试验/NCT06730854
NCT06730854已完成不适用

Association Between Elevated Liver Functions Tests Following Cardiac Surgery and Acute Kidney Injury - a Restrospectiv Single Center Cohort Study

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 3,415 人开始时间: 2024年11月6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
3,415
试验地点
1
主要终点
Association between liver enzymes and acute kidney injury

研究概览

简要总结

A sudden decline in function of the kidneys is a common problem that can happen after heart surgery. It can have serious effects on a patient's recovery and long-term health, potentially leading to permanent kidney problems or heart-related issues. One of the main reasons kidney problems occurs is due to changes in blood flow caused by the heart not pumping well enough. These changes may harm the kidneys, but other organs as well such as the liver.

This study aims to find out if there is a relationship between elevated levels of liver function blood tests and the decline in kidney function.

详细描述

In this study data will be retrospectively collected from the intensive care patient management system for patients admitted postoperatively to the cardiac intensive care unit (ICU) following cardiac surgery. The inclusion period spans from 2012 to 2017 (5 years) and includes about 3,500 patients.

For all included patients, retrospective data collection will include variables related to renal function, fluid balance, hemodynamics, and transaminase levels. Additionally, demographic information, surgical procedure details, comorbidities, and laboratory values will be gathered.

Cardiac surgery-associated acute kidney injury (CSA-AKI) has a multifactorial etiology influenced by non-modifiable factors such as age, comorbidities (e.g., heart failure/ejection fraction, chronic kidney disease, hypertension, diabetes), medication use (NSAIDs, ACE inhibitors/ARBs), type of surgery, duration of surgery/cardiopulmonary bypass time. Central venous pressure (CVP) can serve as a marker of venous congestion, which may contribute to the development of AKI. Venous congestion may also result in elevated transaminase levels.

The primary aim of this study is to investigate the association between postoperative transaminase elevation in the ICU and the development of AKI during the intensive care stay. Data about transaminases will be collected in the first 24 hours after ICU admission. The occurrence of AKI and its severity will be investigated within 72 hours after cardiac surgery. Furthermore, the relationship between the transaminase elevation and the severity of acute kidney injury will be examined, as well as the association between central venous presure (CVP) and transaminase levels postoperatively in the ICU.

Acute kidney injury will be defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria, with severity classified based on the KDIGO staging system.

研究设计

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

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

  • 18 years old or older
  • admission on intensive care after cardiac surgery
  • available data about liver enzymes

排除标准

  • chronic kidney disease with (estimated) glomerular filtration rate below 30mL/min/1.73 m2 or renal replacement therapy (RRT) dependent
  • patient on extracorporal membrane oxygenator (ECMO) before or after cardiac surgery
  • patient with or planned surgery for Left ventricular assist device (LVAD)
  • inotropics or vasopressore before surgery

结局指标

主要结局

Association between liver enzymes and acute kidney injury

时间窗: Data about liver enzymes will be collected at ICU admission, and 12 hours and 24 hours after ICU admission. The occurrence of acute kidney injury within 72 hours after ICU admission will be investigated

Investigation of the association between liver enzymes (alanine aminotransferase (AST); aspartate aminotransferase (ALT)) and development of acute kidney injury. Data about liver enzymes will be collected at ICU admission, and 12 hours and 24 hours after ICU admission. AKI is defined by the Kidney Disease Improving global outcome definition by using both the serum creatinine and urine output criteria.

次要结局

  • Association between liver enzymes and the severity of acute kidney injury(Data about liver enzymes will be collected at ICU admission, and 12 hours and 24 hours after ICU admission. The occurrence of the different severity stages of acute kidney injury within 72 hours after ICU admission will be investigated)
  • association of central venous pressure with elevated liver enzymes and acute kidney injury(Data about central venous pressure will be collected during the first 24 hours after ICU admission.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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