scholarly journals 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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zheng Guan ◽  
Yanfeng Gao ◽  
Qiao Qiao ◽  
Qiang Wang ◽  
Jingjie Liu
Keyword(s):  
High Risk ◽  
Fluid Therapy ◽  
Enhanced Recovery ◽  
Controlled Trial ◽  
Fluid Infusion ◽  
High Risk Patients ◽  
Thoracoscopic Lobectomy ◽  
Risk Patients ◽  
Goal Directed Fluid Therapy ◽  
Eras Protocol

Abstract 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.govNCT04302467. Registered on 26 February 2020

scholarly journals Polysaccharide hemostatic powder to prevent bleeding after endoscopic submucosal dissection in high risk patients: A randomized controlled trial

Endoscopy ◽  
2020 ◽  
Author(s):  
Da Hyun Jung ◽  
Chan Hyuk Park ◽  
Hee Seok Moon ◽  
Jun Chul Park
Keyword(s):  
High Risk ◽  
Endoscopic Submucosal Dissection ◽  
Controlled Trial ◽  
Gastric Neoplasms ◽  
Control Group ◽  
High Risk Patients ◽  
Randomized Controlled ◽  
Submucosal Dissection ◽  
Risk Patients ◽  
Hemostatic Powder

Background and aims: Bleeding after endoscopic submucosal dissection (ESD) is a severe adverse event. Several methods to prevent post-ESD bleeding (PEB) have been introduced; however, they have not been widely used because of technical difficulties. We aimed to investigate whether polysaccharide hemostatic powder (PHP), which is very easy to apply, can prevent early PEB, especially in patients with high risk of PEB. Methods: This was a prospective, multicenter, randomized, open-label, controlled trial. Patients with a high risk for PEB were enrolled. Patients with gastric neoplasms in whom the resected specimen size was expected to be >40 mm and those who were regularly taking antithrombotic agents were defined as high-risk patients. Patients were randomly assigned to the PHP or control group. Results: Between May 2017 and September 2018, 143 patients were enrolled (PHP group: 73, control group: 70). The total PEB rate was 6.3% (PHP group: 5% vs. control group: 7.1%, P=0.742). There was no bleeding within 7 days after ESD in the PHP group. Continued antithrombotic use was an independent risk factor of PEB. In subgroup analysis excluding patients who continued to take antithrombotics (n=129) during ESD, the rate of PEB was tended to be lower in the PHP group than in the control group (0% vs. 6.3%, P=0.058). Conclusion: PHP did not demonstrate a significant effect on the prevention of PEB in this study. Further larger-scale, randomized controlled trials are needed to confirm this.(ClinicalTrials.gov 03169569)

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