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临床试验/NCT01171352
NCT01171352撤回不适用

Predicting Hypotension During Dialysis in the ICU

Oregon Health and Science University1 个研究点 分布在 1 个国家开始时间: 2010年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
hypotensive episode

研究概览

简要总结

Currently, decisions regarding volume management for dialysis sessions in the ICU are made in large part on the nephrologists'/intensivists' overall gestalt. This gestalt is based upon a combination of commonly used measures of circulatory function, the physical exam, fluid balance, estimates of dialysis dry weight, and monitoring changes in relative blood volume status using devices such as the Crit-Line™ III, and central venous pressures. However, these tools perform poorly in predicting the circulatory system's overall response to dialysis. Consequently, episodes of dangerously low blood pressure are still frequently encountered. Better techniques to predict the circulatory system's response to dialysis are much needed. The intent of this study is to test newer metrics of circulatory system function for their ability to predict low blood pressure episodes during dialysis. This is important because it may enable the design of newer treatment strategies created to prevent low blood pressure episodes during dialysis and improve patient outcomes. The investigators overall hypothesis is that newer measures of vascular volume and dynamic indices of fluid responsiveness, previously found to better reflect cardiac preload state than currently used parameters, will better predict low blood pressure episodes during dialysis than current methods.

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

  • Admitted to OHSU Hospitals ICUs
  • Patient has acute or chronic needs for intermittent hemodialysis support during their ICU stay for any reason other than isolated hyperkalemia
  • Central venous access in place separate from the dialysis catheter, or arteriovenous fistula or graft
  • Two or more organ systems affected by critical illness requiring supportive care as documented in the medical chart.

排除标准

  • age younger than 18 years old
  • Weight > 160 kg
  • burns greater than 40% total body surface area
  • known cardiac or vascular aneurysm
  • contraindications to femoral arterial puncture
  • diagnosis of peripheral vascular disease
  • not committed to full support
  • participation in other experimental medication trial within 30 days
  • current atrial or ventricular arrhythmias
  • history of sever CHF- NYHA class >= III, previously documented EF < 30%
  • severe aortic regurgitation
  • anticipated ICU stay < 24 hrs
  • not expected to require dialysis > 48 hours

结局指标

主要结局

hypotensive episode

时间窗: during or within one hour post dialysis

A mean arterial pressure of \<60 mmHg, a 15% decrease from baseline systolic blood pressure at the start of the dialysis treatment regardless of modality, the need for fluid bolusing \>7 mL/kg body weight, or initiation or increase of vasopressor medication in order to maintain MAP \>60 mmHg.

次要结局

  • fluid removal tolerance(during the 4 hours following parameter measurement in dialysis)
  • predicted volume of fluid that can be removed without hypotensive events(during dialysis)
  • mortality in the ICU(duration of ICU stay)
  • All cause mortality(30 days)
  • Length of stay in ICU(ICU stay duration)
  • Length of stay in hospital(duration of hospital stay)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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