RecruitingNot ApplicableNCT05149196

Goal-directed Hemodynamic Management and Kidney Injury After Radical Nephrectomy or Nephroureterectomy

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


Sponsor

Peking University First Hospital

Enrollment

1,724 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether a goal-directed approach to managing blood pressure and fluid during kidney removal surgery (nephrectomy) can reduce the risk of kidney injury afterward. **You may be eligible if...** - You are 18 or older - You are scheduled for removal of one kidney due to kidney cancer or upper urinary tract cancer **You may NOT be eligible if...** - You already have advanced chronic kidney disease (stage 4 or 5, GFR below 30) - You have severe uncontrolled high blood pressure - You have significant heart disease or low exercise tolerance (RCRI above 1 or METs below 4) - You cannot communicate due to severe dementia, language barrier, or end-stage disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTargeted hemodynamic 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.

OTHERRoutine care

During anesthesia, hemodynamic managements are conducted according to routine practice and usually include fluid 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.


Locations(1)

Beijing University First Hospital

Beijing, Beijing Municipality, China

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NCT05149196


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