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临床试验/NCT03753607
NCT03753607已完成不适用

Changes in Doppler-derived Renal Venous Flow and Adverse Renal Outcomes Following Cardiac Surgery

University of Giessen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年12月20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
200
试验地点
1
主要终点
Association between perioperative changes in Doppler-derived renal venous venous flow and CSA-AKI

研究概览

简要总结

The prospective single-center study investigates the association between changes in Doppler-derived renal venous flow and cardiac surgery-associated acute kidney injury (CSA-AKI).

详细描述

CSA-AKI is a common postoperative complication in patients undergoing open heart surgery, and is associated with increased mortality and morbidity. Venous congestion has been identified as the principal cause of cardiorenal decompensation in patients with heart failure but the relative contribution of congestion-driven renal function decline in CSA-AKI is not well studied.

The prospective single-center study investigates whether serial Doppler-derived renal venous flow assessments could help identify subset of patients with cardiorenal syndrome and subclinical renal congestion at high risk of CSA-AKI.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Inclusion criteria:
  • Subjects older than 18 years
  • Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)
  • Subjects who signed informed consent forms

排除标准

  • Patients requiring mechanical ventilation
  • Patients with mechanical circulatory assist devices or extracorporeal membrane oxygenation
  • Patients with stage 3 AKI with renal replacement therapy (RRT) or life- threatening volume overload treated with RRT
  • Stage ≥4 chronic kidney disease (CKD) stage
  • CKD requiring extracorporeal or peritoneal ultrafiltration for diuretic-resistant volume overload, 6) 6) Prediagnosed glomerulonephritis
  • Autosomal dominant polycystic kidney disease, postrenal obstruction, or solid organ transplantation
  • Anticipated life expectancy of <12 months
  • Likelihood of receiving advanced therapy (mechanical circulatory assist device/cardiac transplant)
  • Pregnancy or possibility of pregnancy in the next 3 months
  • Rhabdomyolysis

结局指标

主要结局

Association between perioperative changes in Doppler-derived renal venous venous flow and CSA-AKI

时间窗: preoperative, 24 hours postoperative, hospital discharge

Doppler-derived renal venous flow

次要结局

  • Association of changes in postoperative renal venous flow profiles with renal recovery at hospital discharge(Measured at Day 1 and Day 7 postoperative)
  • Estimated GFR trajectory up to 3 months post-cardiac surgery relative to kidney(Measured at 3 months post-surgery)

研究者

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

Faeq Husain-Syed

Senior physician

University of Giessen

研究点 (1)

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