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临床试验/NCT05984563
NCT05984563终止不适用

Official Title Optimization Strategy to Predict and Individualize Oxygen Delivery During Cardiac Surgery Under Cardiopulmonary Bypass

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
6
试验地点
1
主要终点
values oF D02 calculated with the CONNECT software (LivaNova, London, United Kingdom) using CPB output and hemoglobin values (measured using Spectrum Medical M4) (standard care)

研究概览

简要总结

Cardiac surgery is a frequent procedure that can lead to serious complications, including acute kidney injury (AKI) or postoperative delirium. During the intervention, a cardiopulmonary bypass (CPB) is used to ensure tissue perfusion and oxygen delivery (DO2). The hypothesisis that an individualized strategy to optimize DO2 during CPB could decrease complications rate after cardiac surgery. Indeed, it is known that DO2 depends on CPB output, hemoglobin level and O2 tension. To this day, a DO2 threshold below 280 mL is known to be associated with postoperative AKI. From these data, a "Goal Directed Perfusion" strategy is widely used to maintain a DO2 above this threshold during CPB. But DO2 decrease in unpredictable, and the other factors influencing DO2 interindividual variability are not known. Moreover, the relation between DO2 and tissue perfusion is not well established, as DO2 requirement could differ between individuals or organs. Population approach using nonlinear mixed models is a method used to optimize drug administration with pharmacokinetics and pharmacodynamics models. Using this method, the aim of this study is to evaluate DO2 variability during CPB and develop a model to optimize GDP strategy.

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

入选标准

  • Patients aged over 18
  • Patients scheduled for elective cardiac surgery under CPB at the university hospital of Lille, France
  • Patients with given written consent
  • Patient insured under the French social security system

排除标准

  • Pregnant or breastfeeding
  • Off pump cardiac surgery
  • Lack of DO2 monitoring
  • Emergency surgery (infectious endocarditis, aortic dissection, cardiac transplantation, LVAD implantation) Uncontrolled sepsis

结局指标

主要结局

values oF D02 calculated with the CONNECT software (LivaNova, London, United Kingdom) using CPB output and hemoglobin values (measured using Spectrum Medical M4) (standard care)

时间窗: Every 20 to 30 seconds during CPB (standard care) and up to 28 days

次要结局

  • Incidence of postoperative deliriumassessed by CAM-ICU, CPC and mRS scores(up to 48 hours postoperative)
  • Incidence of postoperative AKI using creatinine measurement (standard care)(up to 48 hours postoperative)
  • Vital status checklist(up to 28 days postoperative)

研究者

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

研究点 (1)

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