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临床试验/NCT01862588
NCT01862588Unknown不适用

Clinical Study of Renal Resistive Index and Hemodynamic Parameters Changes Caused by Fluid Resuscitation to Predict the Occurrence of Acute Kidney Injury in Septic Shock Patients

Zhongda Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年1月最近更新:
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
7 days AKI occurrence

研究概览

简要总结

Record the renal resistive index and hemodynamic parameters ( record the cardiac output and stroke volume if the patient's next to kin agree to undertake a PiCCO monitoring ) before and after resuscitation for severe sepsis or septic shock patients, to determine whether the changes of resistive index or hemodynamic parameters, especially the cardiac output can be a better parameter to predict AKI

详细描述

  • Purpose: To examine whether the resuscitation-induced changes of renal resistive index or hemodynamic parameters has the superiority as a valid tool to evaluate the renal perfusion improvement and whether the changes can better predict AKI occurrence in severe sepsis or septic shock patients.
  • Methods: Measure the renal resistive index and take record of hemodynamic parameters (use a PiCCO monitoring to measure cardiac output if the patient's next to kin agree to undertake such a catheter ) before and after successful resuscitation for severe sepsis or septic shock patients, followup to determine the occurrence of AKI and mortality.
  • Hypothesis: The changes of resistive index or cardiac output during shock resuscitation may be a better parameter to evaluate renal perfusion and predict AKI, and may have a better value to guide renal protective therapy in septic shock.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥18 years, Sex unlimited
  • Arriving ICU in 6 hours and diagnosed with severe sepsis or septic shock
  • Physician in charge decide that an aggressive fluid resuscitation was in order

排除标准

  • Pregnancy, Age <18 years
  • Ongoing recovery from AKI
  • Known end-stage renal disease or chronic kidney disease(glomerular filtration rate <30mL/min/1.73m2)
  • Known other causes of shock morbidly
  • conditions known to modify RRI, such as renal-artery stenosis, intra-abdominal hypertension(>35cmH2O)

结局指标

主要结局

7 days AKI occurrence

时间窗: 7 days

Follow up to determine the occurrence of AKI in 7 days after inclusion.

次要结局

  • eGFR(until 6 hours after enrollment)

研究者

发起方
Zhongda Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaohua Qiu

physician

Zhongda Hospital

研究点 (1)

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