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临床试验/NCT04954066
NCT04954066已完成不适用

Association Between Muscular Tissue Oxygen Saturation and Postoperative Acute Kidney Injury in Older Patients Undergoing Major Abdominal Surgery: A Prospective Cohort Study

General Hospital of Ningxia Medical University1 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2021年9月11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
253
试验地点
1
主要终点
the incidence of AKI in 7 days

研究概览

简要总结

The aim of this study is to investigate association between muscular oxygen saturation and postoperative acute kidney injury(AKI) in older patients undergoing abdominal surgeries.The investigator also intend to explore the thresholds of muscular oxygen saturation that correlate with a reduced risk of AKI and therefore have the potential to be used as therapeutic targets in future.

详细描述

Acute kidney injury is one of the common and serious complications after major abdominal surgeries,which a reported incidence is as high as 7.5-13.4%.The evidence shows that nearly 20% of elder patients with comorbidity are severely related to postoperative AKI,which lead to increased complications, prolonged stays in hospital and higher mortality.What'more,even smaller increases in the levels of serum creatinine (sCr) may predict worse kidney function after 1or 2 years.But there is no effective treatment or strategy for acute kidney injury at the moment.Therefore,early identification and prevention for AKI in perioperative period are key points.

The mechanism of AKI is complex and multifaceted,which includes that surgeries or anesthesia lead to renal hypoperfusion,ischemia and hypoxia. If the anesthesiologists can monitor the oxygenation status of renal tissues and improve it during surgery, it may reduce the incidence of AKI.

Near-infrared spectroscopy (NIRS) is a new noninvasive technique that continuously monitors tissue oxygen saturation by measuring the relative concentrations of oxygenated and deoxygenated hemoglobin within a local tissue area.It has been improved that perioperative muscular oxygen saturation is related to patients outcome.A observational study showed an association between lower intraoperative tissue oxygen saturation monitored on both sides of paraspinal muscle and higher risk of postoperative AKI in patients having cardiac surgery, suggesting a potential similarity of tissue perfusion and oxygenation between renal and muscular tissue beds.

Therefore,in this study, the investigator hypothesizes that monitoring muscular oxygen saturation during period may reflect some part of renal tissue oxygen saturation and associate with postoperative AKI.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥65 years old,
  • ASA scoreⅠ-Ⅲ,
  • Scheduled to undergo a 2-hour-or-longer elective major abdominal surgeries

排除标准

  • Urological surgery or procedure related to renal tissue may be performed during surgeries.
  • Nephrectomy or partial nephrectomy was performed before surgeries.
  • Preoperative glomerular filtration rate<30ml/1.73m2, or end-stage renal disease or renal transplant.
  • Poor hearing or vision and language barrier impeding postoperative assessment.
  • Skin condition incompatible with the adhesive oximetry probe.
  • Refuse to participate in the trial.

结局指标

主要结局

the incidence of AKI in 7 days

时间窗: All the patients will be observed in previous 7 days after surgery for AKI.

Postoperative AKI will be diagnosed according to KDIGO(Kidney Disease Improving Global)as one of the following: An increase in serum creatinine by≥0.3 mg/dl ( ≥26.5μmol/l) within 48 h; An increase in serum creatinine to ≥1.5 times baseline within the previous 7 days; Urine volume≤0.5 ml/kg/h for 6 h.

次要结局

  • the incidence of other complications,hospital stays and mortality in 30 days(All the patients will be followed up within 30 days after surgery.)

研究者

发起方
General Hospital of Ningxia Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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