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临床试验/NCT03632538
NCT03632538Unknown不适用

Prospective Analysis of Postoperative Occurrence of Acute Kidney Injury (AKI) and Need for Renal Replacement Therapy After Cardiac Surgery With the Help of New Biomarkers.

University of Rostock1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年7月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
AKI 6 h

研究概览

简要总结

Acute kidney injury (AKI) is a common and major complication of cardiac surgery. The aim of this study is to evaluate the use of a fragment of proencephalin in plasma and other biomarkers as specific markers for early diagnosis of AKI and the need of renal replacement therapy after cardiac surgery.

详细描述

Acute kidney injury (AKI) is an abrupt loss of kidney function and occurs in up to 5-40% of patients who undergo cardiac surgery; dialysis being required in approximately 2-15% of all patients. AKI is a common problem in critically ill patients and is independently from underlying diseases associated with increased morbidity and mortality (to progressive loss of kidney function, cardiovascular disease, and death). Unfortunately, chronic kidney disease is often overlooked in its earliest, most treatable stages. Implementation of novel biomarkers into the clinical practice that reliably identify patients at risk or at an early stage of AKI could offer more efficient management strategies may lead to better outcomes in critically ill patients.

Kidney disease usually progresses silently, often destroying most of the kidney function before causing any symptoms. AKI was defined using the Kidney Disease Improvement Global Outcome (KDIGO) definition. The standard key tests (increase of serum creatinine and urine output) are late parameters after significant kidney injury.

In this study 20 female and 20 male adult patients before and after cardiac surgery should be included. From all patients basic demographic data, pre-morbidity, vital parameters, blood parameters, urine output, Illness severity scores (APACHE-II, SOFA, GCS), drug levels, microbiological results will be recorded. The aim of this study is to evaluate the use of a fragment of proencephalin in plasma "penKID", Spingotec GmbH, Berlin, Germany) and other biomarkers (ADM: adrenomedulin, CAAP: C-terminal alpha-1 antitrypsin peptide) as specific markers for early diagnosis of AKI and the need of renal replacement therapy. Bio-ADM is a water-soluble peptide hormone with a molecular weight of about 6kDa released mainly by endothelial cells. Its biological function is the control of vasodilation, an important regulator of blood pressure and organ perfusion. This biomarker predicts and diagnoses endothelial dysfunctions. C-terminal alpha-1 antitrypsin peptide (CAAP) is a novel sepsis and renal injury biomarker with immunomodulatory function, especially in human neutrophils, which supports its role in the host response and pathophysiology of sepsis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Female or male, at least 18 years old
  • Ability to consent to the study by patient or legal representative
  • Cardiac surgery with use of extracorporeal circulation (ECC)
  • Bypass (> 2; ACB) or bypass + heart valve surgery
  • Two or three heart-valve operation

排除标准

  • Dialysis-dependent patients with chronic, end-stage renal failure
  • Pre-existing renal replacement therapy
  • Infused prognosis (expected death in ≤ 12 hours despite maximal therapy)
  • Inability to consent of participation in the research project, of the patient or of the patients representative
  • Aortic surgery
  • Endocarditis
  • (Only) partial sternotomy (eg. aortic valve surgery)

结局指标

主要结局

AKI 6 h

时间窗: after operation (surgery): 6 hours

Diagnosis and severity of acute kidney injury following the KDIGO-criteria

AKI 0 h

时间窗: after operation (surgery): 0 hours

Diagnosis and severity of acute kidney injury following the KDIGO-criteria

次要结局

  • SOFA(before operation, after operation (times: 0, 6, 24, 72 and 168 hours)

研究者

发起方
University of Rostock
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Martin Sauer, MD

Principal Investigator, PD Dr. med. habil.

University of Rostock

研究点 (1)

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