Abstract
BackgroundAcute 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/designThis 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.DiscussionThis 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 registrationClinicalTrials.govNCT04302467. Registered on 26 February 2020
Highlights
Acute kidney injury (AKI) is a common complication after thoracoscopic lobectomy in high-risk patients due to insufficient intraoperative infusion
Guan et al Trials (2021) 22:36 (Continued from previous page). This is the first study to compare intraoperative Goal-directed fluid therapy (GDFT) with restrictive fluid therapy combined with an Enhanced recovery after surgery (ERAS) protocol on the incidence of acute kidney injury (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
Summary
AKI is a severe complication, associated with a high incidence of morbidity and mortality. Many definitions of decreased kidney function have been published; in this study, we used the Kidney Disease Improving Global Outcomes (KDIGO) guideline for the identification of AKI [13]; this definition can increase physicians’ attention to kidney dysfunction as early as possible. We focus on high-risk patients, because elderly, low FEV1, and coronary artery disease all are risk factors of AKI after thoracic surgery [2], and cardiopulmonary complications are common after thoracoscopic lobectomy in high-risk patients [14]. GDFT is based on the measurement of functional hemodynamic variables, and it can regulate fluid management precisely. GDFT can decrease the incidence of postoperative complications in different kinds of operation [16]. Trial status Following the approval of the study protocol (XJTU1AF2019LSL-012), the current protocol version was approved on 9 December 2019, and the recruitment of subjects will be commenced in April 2020 and will be completed in March 2022
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
