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临床试验/NCT05836922
NCT05836922招募中不适用

Association Between Renal Regional Oxygen Saturation Measured by Near-InfraRed Spectroscopy and Postoperative Renal Failure After Lung Transplantation Surgery: A Pilot Study

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Occurrence of early postoperative acute renal failure up to the fifth postoperative day

研究概览

简要总结

Complications after lung transplantation are almost ubiquitous, among which postoperative acute renal failure may represent more than 50% of lung transplant patients and require extrarenal purification in 5 to 13% of cases.

Multiple factors are associated with postoperative acute renal failure. These factors can be classified into preoperative, intraoperative, and postoperative factors. While some postoperative complications are explained by donor and recipient factors, the literature suggests that certain intraoperative events represent modifiable or avoidable risk factors that could be targeted by therapeutic interventions to reduce the risk of postoperative acute renal failure. Some of these factors (intraoperative hemodynamic instability, significant bleeding or hypoxemia) can generate renal hypoxic aggression, alone or in combination. However, to date, there is no validated tool available at the patient's bedside during surgery to detect renal hypoxia or guide interventions to restore renal perfusion during surgery. Yet, as recent recommendations suggest, intraoperative renal protection is an important axis for improving the outcome of lung transplant patients, to the extent that the recommendations of Marczin et al. recommend the establishment of a renal prevention protocol for each patient. Without a tool to guide this plan intraoperatively, anesthesia teams can't establish a renal prevention protocol. This research aims to establish whether renal NIRS is a reliable tool for monitoring intraoperative renal hypoxic aggression predictive of postoperative renal failure.

Near-infrared spectroscopy (NIRS) is an optical technology that allows non-invasive measurement of tissue oxygen saturation. This technique is commonly used for intraoperative monitoring of cerebral perfusion in adults and children. Some studies have shown that regional renal oxygen saturation (renal rSO2) measured by NIRS during aortic-coronary bypass surgery under extracorporeal circulation (ECC) is correlated with renal venous oxygen saturation measured by catheterization. It is also associated with the risk of postoperative acute renal failure in patients undergoing cardiac surgery under ECC. However, there are no equivalent data in lung transplant patients, who frequently present with postoperative acute renal failure. In the available literature, no clear threshold of renal desaturation has been established. Because it is assumed that the depth of renal desaturation can be particularly deleterious, in addition to desaturation time, the investigator have chosen to retain in this project the integral of time and magnitude spent under a renal desaturation threshold, aggregated into a renal hypoxia index, during the intraoperative period.

The primary objective of this research is to demonstrate the usefulness of measuring the intraoperative renal hypoxia index in predicting the risk of early postoperative acute renal failure

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

  • patient undergoing a lung transplant (mono or bi-transplantation)
  • Age >= 18 years
  • Affiliated to the French social security system

排除标准

  • Renal anatomical abnormality likely to induce a misleading NIRS signal: single kidney, polycystic kidney disease.
  • Expression of opposition to participation in the research protocol.
  • Hyperbilurbinemia > 17mmol/l
  • Preoperative Extra Corporeal Membran Oxygenation (ECMO).
  • Preoperative mechanical ventilation

结局指标

主要结局

Occurrence of early postoperative acute renal failure up to the fifth postoperative day

时间窗: 5 days postoperative

Occurrence of early postoperative chronic kidney injury up to the fifth postoperative day, as defined by KDIGO (KDIGO stage 1 or higher).

次要结局

  • Use of Extrarenal Purification(5 days postoperative)
  • Vital status(5 days postoperative)
  • maximum variation in serum creatinine(5 days postoperative)
  • average glomerular filtration rate(5 days postoperative)
  • occurrence of primary graft dysfunction(5 days postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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