目标导向液体治疗与限制液体治疗联合加速康复外科方案对高危患者胸腔镜肺叶切除术后并发症的影响：一项前瞻性随机对照试验的研究方案。
Effects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trial.
机构信息
Department of Anesthesiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, People's Republic of China.
Department of Neurology, the Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, People's Republic of China.
出版信息
Trials. 2021 Jan 7;22(1):36. doi: 10.1186/s13063-020-04983-y.
BACKGROUND
Acute kidney injury (AKI) is a common complication after thoracoscopic lobectomy in high-risk patients due to insufficient intraoperative infusion. Goal-directed fluid therapy (GDFT) is an individualized fluid infusion strategy; the fluid infusion strategy is adjusted according to the patient's fluid response. GDFT during operation can reduce the incidence of AKI after major surgery. Enhanced recovery after surgery (ERAS) protocol optimizes perioperative interventions to decrease the postoperative complications after surgery. In ERAS protocol of lobectomy, intraoperative restrictive fluid therapy is recommended. In this study, we will compare the effects of intraoperative GDFT with restrictive fluid therapy combined with an ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high-risk patients.
METHODS/DESIGN: This is a prospective single-center single-blind randomized controlled trial. Two hundred seventy-six patients scheduled for thoracoscopic lobectomy are randomly allocated to receive either GDFT or restrictive fluid therapy combined with an ERAS protocol at a 1:1 ratio. The primary outcome is the incidence of AKI after operation. The secondary outcomes include (1) the incidence of renal replacement therapy, (2) the length of intensive care unit stay after operation, (3) the length of hospital stay after operation, and (4) the incidence of other complications including infection, acute lung injury, pneumonia, arrhythmia, heart failure, myocardial injury after noncardiac surgery, and cardiac infarction.
DISCUSSION
This is the first study to compare intraoperative GDFT with restrictive fluid therapy combined with an ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high-risk patients. The hypothesis is that the restrictive fluid therapy is noninferior to GDFT in reducing the incidence of AKI, but restrictive fluid therapy is simpler to apply than GDFT.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04302467 . Registered on 26 February 2020.
背景
由于术中输液不足，高危患者行胸腔镜肺叶切除术后常并发急性肾损伤（AKI）。目标导向液体治疗（GDFT）是一种个体化的液体输注策略；根据患者的液体反应调整液体输注策略。术中 GDFT 可降低大手术后 AKI 的发生率。加速康复外科（ERAS）方案优化了围手术期干预措施，以减少手术后的并发症。在肺叶切除术的 ERAS 方案中，建议术中采用限制性液体疗法。本研究旨在比较术中 GDFT 与限制性液体疗法联合 ERAS 方案对高危患者胸腔镜肺叶切除术后 AKI 发生率的影响。
方法/设计：这是一项前瞻性单中心单盲随机对照试验。将 276 例拟行胸腔镜肺叶切除术的患者随机分为 GDFT 组或限制性液体疗法联合 ERAS 方案组，1:1 比例分配。主要结局为术后 AKI 的发生率。次要结局包括：（1）肾脏替代治疗的发生率；（2）术后 ICU 住院时间；（3）术后住院时间；（4）其他并发症的发生率，包括感染、急性肺损伤、肺炎、心律失常、心力衰竭、非心脏手术后心肌损伤和心肌梗死。
讨论
这是第一项比较高危患者胸腔镜肺叶切除术后术中 GDFT 与限制性液体疗法联合 ERAS 方案对 AKI 发生率影响的研究。假设限制性液体疗法在降低 AKI 发生率方面不劣于 GDFT，但限制性液体疗法比 GDFT 更简单。
试验注册
ClinicalTrials.gov NCT04302467。于 2020 年 2 月 26 日注册。
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