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临床试验/NCT04286490
NCT04286490已完成不适用

Effect of Prone Position on Renal Resistive Index Among Patients With Acute Respiratory Distress Syndrome. The Role of Intra-abdominal Pressure

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
change in renal resistive index (RRI)

研究概览

简要总结

Patients suffering from Acute Respiratory Distress Syndrome (ARDS) with a prone position (PP) indication will benefit from measurements of renal resistive index, intra-abdominal pressure (IAP), urinary oxygen tension (uPO2) and ventilatory mechanics in supine position (baseline IAP), after 2 hours in PP at the current IAP value, thirty minutes after patients' abdomen suspension in order to resume baseline IAP and after patients' are turned back to supine position.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • ARDS patients according to Berlin criteria, intubated, mechanically ventilated
  • with PaO₂/FiO₂ < 150 mmHg,
  • neuromuscular blockade
  • with an indication of PP done by the physician in charge
  • possibility to differ PP for one hour
  • patients should be hemodynamically stable since at least 4 hours

排除标准

  • Pregnant or breast-feeding women
  • legal protection, no social security affiliation
  • PP contra-indication
  • nasogastric tube contra-indication
  • extra corporeal membrane oxygenation
  • acute kidney injury at inclusion according to K-DIO criteria, chronic kidney disease defined as an estimated glomerualr filtration rate less than 30 ml/min/1.73m², kidney transplantation, renal artery stenosis, solitary kidney, albuminuria > 1.25 mg/ml
  • cardiac arrhythmia
  • advanced cirrhosis

结局指标

主要结局

change in renal resistive index (RRI)

时间窗: At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver

RRI measurement will be performed on a right kidney arcuate/interlobar artery, with a high frequency Doppler probe. Three to five consecutive measures will be obtained then RRI computed according to the formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity).

次要结局

  • change in renal medullary oxygen tension(At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver)
  • Persisting effect of IAP increase in prone position when patients are back in supine position on urinary PO2(Two hours after patients are back in supine position)
  • ventilatory mechanics: transpulmonary pressure(At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver)
  • ventilatory mechanics: driving pressure(At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver)
  • ventilatory mechanics: elastance(At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver)
  • haematosis(At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver)
  • Intra abdominal pressure(At inclusion (in supine position), two hours after prone positioning, 30-minutes after the abdomen suspension maneuver and two hours after patients are back in supine position)
  • Persisting effect of IAP increase in prone position when patients are back in supine position on renal resistive index(Two hours after patients are back in supine position)
  • Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: transpulmonary pressure(Two hours after patients are back in supine position)
  • Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: driving pressure(Two hours after patients are back in supine position)
  • Persisting effect of IAP increase in prone position when patients are back in supine position on ventilatory mechanics: elastance(Two hours after patients are back in supine position)
  • Persisting effect of IAP increase in prone position when patients are back in supine position on haematosis(Two hours after patients are back in supine position)
  • Acute kidney injury(within 48 hours following prone position)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (2)

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