Impact of Goal-directed Hemodynamic Management on Occurrence of Acute and Persistent Kidney Injury After Radical Nephrectomy or Nephroureterectomy: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Radical nephrectomy and nephroureterectomy are common operations for the treatment of renal cell carcinoma and upper tract urothelial carcinoma, respectively. However, acute kidney injury frequently occurs 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 kidney injury after surgery but requires further demonstration. We hypothesized that goal-directed hemodynamic management combining hydration, inotropes, and forced diuresis to maintain pulse pressure variation \<9%, mean arterial pressure ≥85 mmHg, and urine flow rate \>200 ml/h (3 ml/kg/h) may reduce the incidence of acute kidney injury and improve long-term renal outcome after radical nephrectomy or nephroureterectomy. The purpose of this study is to investigate the effect of goal-directed hemodynamic management on the occurrence of acute and persistent kidney injury in patients following radical nephrectomy and nephroureterectomy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age of 18 years or older;

• Scheduled to undergo unilateral radical nephrectomy for renal cancer or unilateral radical nephroureterectomy for upper tract urothelial carcinoma.

Locations
Other Locations
China
Beijing University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Dong-Xin Wang, MD,PhD
wangdongxin@hotmail.com
86 10 83572784
Backup
Qiongfang Wu, MD
wuqf91@163.com
86 83575138
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2034-12-30
Participants
Target number of participants: 1724
Treatments
Experimental: Targeted blood pressure management
During anesthesia, hemodynamic managements include active hydration (\>10 ml/kg/h), use of inotropes (dobutamine), and forced diuresis; the targets are to maintain pulse pressure variation \<9%, mean arterial pressure ≥85 mmHg, and urine output \>200 ml/h (3ml/kg/h).~During the first 48 hours after surgery, systolic blood pressure is maintained ≥110 mmHg or within 20% of baseline by delaying antihypertensive resumption, providing fluid challenge, and/or vasoactive infusion.
Active_comparator: Routine care
During anesthesia, hemodynamic managements are conducted according to routine practice and usually include fluids infusion at a rate of 6-8 ml/kg/h without inotropics; the targets are to maintain mean arterial pressure ≥60 mmHg and urine output \>0.5 ml/kg/h.~During the first 48 hours after surgery, hemodynamic management is performed according to routine practice.
Sponsors
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov