Goal-directed Hemodynamic Management and Acute Kidney Injury After Radical Nephrectomy

Acute Kidney Injury Clinical Trial

Official title: Impact of Goal-directed Hemodynamic Management on the Incidence of Acute Kidney Injury and Long-term Outcomes in Patients Undergoing Radical Nephrectomy: A Randomized Clinical Trial

Status Not yet recruiting

Clinical Trial Summary

Radical nephrectomy is a standard operation for the treatment of renal cell carcinoma. However, acute kidney injury frequently occur after surgery. And the occurrence of acute kidney injury is associated with an increased risk of chronic kidney disease. Intraoperative hypotension is identified as an important risk factor of postoperative acute kidney injury. Preliminary studies showed that goal-directed hemodynamic management may reduce organ injury after surgery but requires further demonstration. We hypothesized that goal-directed hemodynamic therapy achieved by combining liquid therapy and vasopressors can reduce the incidence of acute kidney injury after radical nephrectomy. The purpose of this study was to investigate the effect of goal-directed hemodynamic management on the incidence of acute kidney injury in patients following radical nephrectomy.

Clinical Trial Description

Renal cancer accounts for 20.3% of urinary system tumors, and the incidence is still increasing. Surgical resection is the main treatment of renal cancer; radical nephrectomy is the standard operation. Acute kidney injury (AKI) is a common complication after radical nephrectomy, with an incidence of up to 53.9%. AKI is associated with the development of chronic kidney disease (CKD) and is an independent risk factor of new onset CKD in patients without underlying kidney disease. A meta-analysis showed that one year after surgery, patients with AKI had a 2.7-fold increased risk of new onset or progression of CKD and a 4.8-fold increased risk of end-stage renal disease. Moreover, even mild AKI is associated with renal insufficiency 1-2 years after surgery. Taking active measures to reduce the incidence of AKI may improve long-term renal function after radical nephrectomy. Many clinical studies show that intraoperative hypotension is an important risk factor of postoperative kidney injury. For example, a study found that intraoperative mean arterial pressure (MAP) <65 mmHg or a decrease of more than 20% from baseline was associated with an increased risk of postoperative AKI; the risk of AKI increased alone with prolonged duration of hypotension. A recent randomized controlled trial showed that, compared with routine intraoperative blood pressure management, goal-directed hemodynamic management reduced the incidence of organ injury from 63.4% to 46.3% within 30 days after surgery. A meta-analysis included 65 randomized controlled trials with 9308 patients and observed the effect of goal-directed hemodynamic management on postoperative AKI. The results showed that a combination of fluid therapy with vasopressors reduced the incidence of AKI in high-risk patients following major abdominal or orthopedic surgery. In a previous pilot trial of the authors, goal-directed hemodynamic management reduced the incidence of AKI by about 40% in patients following partial nephrectomy. However, the difference was not statistically significant due to insufficient sample size. The purpose of this trial is to investigate whether goal-directed intraoperative hemodynamic management can reduce the incidence of acute kidney injury in patients undergoing radical nephrectomy. ;

Related Conditions & MeSH terms

• Acute Kidney Injury
• Carcinoma, Renal Cell
• Chronic Kidney Diseases
• Hemodynamic Management
• Kidney Diseases
• Nephrectomy
• Renal Cell Carcinoma
• Renal Insufficiency, Chronic
• Wounds and Injuries

• NCT number: NCT05149196
• Study type: Interventional
• Source: Peking University First Hospital
• Contact: Dong-Xin Wang, MD,PhD
• Phone: 86 10 83572784
• Email: wangdongxin@hotmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Completion date: October 2028