1. 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
- Author
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Yan-Feng Gao, Zheng Guan, Qiao Qiao, Jing-Jie Liu, and Qiang Wang
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,Medicine (miscellaneous) ,Lung injury ,Goal-directed fluid therapy ,law.invention ,Study Protocol ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Randomized controlled trial ,030202 anesthesiology ,law ,medicine ,Humans ,Single-Blind Method ,Pharmacology (medical) ,Prospective Studies ,Renal replacement therapy ,Randomized Controlled Trials as Topic ,lcsh:R5-920 ,business.industry ,Acute kidney injury ,030208 emergency & critical care medicine ,Perioperative ,Length of Stay ,medicine.disease ,Intensive care unit ,Surgery ,Heart failure ,Fluid Therapy ,Thoracoscopic lobectomy ,Complication ,business ,Enhanced recovery after surgery ,lcsh:Medicine (General) ,Goals - 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
- Published
- 2021