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临床试验/NCT02831907
NCT02831907已完成不适用

Assessment of Portal Flow Using Bedside Doppler Ultrasonography for the Detection of Portal Pulsatility as a Risk Factor for Acute Kidney Injury in Cardiac Surgery Patients

Montreal Heart Institute1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
146
试验地点
1
主要终点
Acute kidney injury defined by an increase in serum creatinine of ≥150% of baseline or an elevation of 0.3 mg/dL or more within a contiguous period of 48 hours. (KDIGO criteria)

研究概览

简要总结

The purpose of this study is to evaluate the possible association between portal vein flow pulsatility and acute kidney injury after cardiac surgery. Participants will undergo assessment of portal vein flow and intra-renal blood flow using bedside Doppler ultrasound before surgery and daily for three days after cardiac surgery.

详细描述

Acute kidney injury is a frequent complication after cardiac surgery. Venous congestion from right ventricular dysfunction and fluid overload can impair kidney perfusion resulting in the cardio-renal syndrome.

An increase in the variation of blood flow velocity in the portal vein during the cardiac cycle called portal pulsatility is a sign of congestive heart failure. Portal pulsatility occurs when increased central venous pressure results liver venous congestion. The presence of abnormal portal pulsatility could be used as a marker of venous congestions in other organs such as the kidneys. Discontinuous intra-renal vein flow is a risk factor for death or re-hospitalization in heart failure patients and could be seen in patients with portal pulsatility.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • 18 years and older.
  • Undergoing cardiac surgery with the use of cardiopulmonary bypass
  • Able to provide consent.

排除标准

  • Chronic renal replacement therapy before the procedure.
  • Chronic kidney disease stage 5 defined as a estimated glomerular filtration rate by the MDRD equation (eGFR-MDRD) of 15 mL/min/1,73m2 or less.
  • Critical pre-operative state defined as aborted sudden death, preoperative cardiac massage, preoperative ventilation before anaesthetic room, preoperative inotropes or intra-aortic counterpulsation balloon.
  • Patients previously diagnosed with a condition interfering with Doppler evaluation of the portal system: Portal vein thrombosis, Cirrhosis.
  • Patients with documented AKI before surgery.
  • Confirmed or suspected pregnancy.
  • Kidney transplant recipients.

结局指标

主要结局

Acute kidney injury defined by an increase in serum creatinine of ≥150% of baseline or an elevation of 0.3 mg/dL or more within a contiguous period of 48 hours. (KDIGO criteria)

时间窗: 7 days after surgery

The definition of acute kidney injury is based on the KDIGO guidelines

次要结局

  • Mortality(30 days after surgery)
  • Severe acute kidney injury (KDIGO stage 2 or more) defined by an increase in serum creatinine of ≥200% of baseline.(7 days after surgery)
  • Duration of intensive care stay(30 days after surgery)
  • Discontinuous blow flow in renal interlobar vessels(3 days after surgery)
  • Delirium defined as an Intensive Care Delirium Screening Checklist score of 4 or more.(7 days after surgery)
  • Composite endpoint of persistent organ dysfunction (POD) plus death at day 3 and 7(3 days and 7 days after surgery)

研究者

发起方
Montreal Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andre Denault

MD PhD FRCPC ABIM-CCM

Montreal Heart Institute

研究点 (1)

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