跳至主要内容
临床试验/NCT07030179
NCT07030179招募中不适用

The Relationship Between Preoperative Frailty and Postoperative Acute Kidney Injury in Patients Undergoing Non-cardiac Surgery and the Mediating Effect of Intraoperative Blood Pressure: A Prospective Cohort Study

Lanyue Zhu1 个研究点 分布在 1 个国家目标入组 515 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
515
试验地点
1
主要终点
Postoperative acute kidney injury

研究概览

简要总结

The primary objectives of study is to compare the difference in the incidence of postoperative AKI between frail and non-frail patients. The secondary objectives of study was to compare the differences in intraoperative blood pressure fluctuations, the incidence and duration of intraoperative hypotension, postoperative complications, length of hospital stay and hospitalization expenses between frail and non-frail patients, and use mediating effect analysis to examine the magnitude of the effect of intraoperative blood pressure on postoperative acute kidney injury caused by frailty.

详细描述

This study is a single-center prospective cohort study. It is expected to include patients who meet the inclusion and exclusion criteria from July 2025 to February 2026. The demographic characteristics, laboratory indicators, preoperative comorbidities of the patients will be recorded and frailty assessment will be conducted within one week before the operation. The patients were divided into the frail group and the non-frail group. Record the surgery-related information of the patient on the day of the operation. During the operation, vital signs such as the patient's blood pressure and heart rate were routinely detected. The anesthesiologist adopted an experience-guided anesthesia management approach, and the doctor in charge of anesthesia management was also unaware of the patient's frailty status. Record the indicators such as the dosage of anesthetic drugs during the operation, the duration of surgical anesthesia, the use of vasoactive drugs and the fluid intake and output of the patients. The incidence of AKI, the incidence of in-hospital complications, the length of hospital stay and the hospitalization costs of the patients were recorded after the operation.

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
否

入选标准

  • •18 years old or above
  • •Undergo non-cardiac surgery

排除标准

  • •At least one measurement of serum creatinine (SCr) was not conducted before and after the operation
  • •End-stage renal disease (ESRD) that has received dialysis within the past year
  • •Baseline SCr ≥ 4.5 mg/dl (because the clinical criteria for AKI based on elevated SCr may not be applicable to these patients)
  • •Acute kidney injury occurred within 7 days before the operation
  • •No frailty assessment was conducted
  • •The operation time is less than 2 hours

结局指标

主要结局

Postoperative acute kidney injury

时间窗: Within one week after the operation

次要结局

  • Intraoperative blood pressure(During the operation)
  • Postoperative complications(Perioperative period)
  • Hospital stays(Perioperative period)
  • Hospitalization costs(Perioperative period)

研究者

发起方
Lanyue Zhu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lanyue Zhu

Attending Doctor

Zhongda Hospital

研究点 (1)

Loading locations...

相似试验