Goal-directed blood pressure, fluid, and urine management to prevent kidney injury after kidney removal
Official title: Impact of Goal-directed Hemodynamic Management on Occurrence of Acute and Persistent Kidney Injury After Radical Nephrectomy or Nephroureterectomy: A Randomized Controlled Trial
Run by Peking University First Hospital · NCT05149196 · Data updated 2026-11-12
This will try a targeted plan of fluids, medicines, and forced urine output during surgery to see if it reduces acute kidney injury in adults having a radical nephrectomy or nephroureterectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1724 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | February 10, 2025 |
| Main results expected | December 30, 2032 |
| Study ends | December 30, 2034 |
| Registry record updated | June 3, 2025 |
| Trial ID | NCT05149196 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 years or older scheduled for unilateral radical nephrectomy or nephroureterectomy who do not have advanced (stage 4–5) chronic kidney disease, uncontrolled severe hypertension, or high cardiac risk and who can give consent.
✕Probably not a fit
Patients with preexisting advanced CKD (GFR <30 ml/min/1.73 m2), uncontrolled severe hypertension, significant cardiac comorbidity (RCRI >1 or METs <4), or those unable to tolerate the perioperative protocol are unlikely to receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients undergoing unilateral radical nephrectomy or nephroureterectomy are randomized to a goal-directed intraoperative hemodynamic protocol or routine care. The intervention combines guided hydration, inotropic support, and forced diuresis to maintain pulse pressure variation <9%, mean arterial pressure ≥85 mmHg, and urine flow >200 ml/h (≈3 ml/kg/h). The trial measures the incidence of acute kidney injury after surgery and tracks longer-term renal function outcomes. Results will determine whether protocolized hemodynamic control reduces postoperative AKI and subsequent chronic kidney disease risk compared with standard management.
Why it matters
Potential benefit: If successful, this approach could lower the rate of acute postoperative kidney injury and reduce long-term decline in kidney function after nephrectomy.
How similar studies have gone: Preliminary trials and meta-analyses have suggested goal-directed hemodynamic management can reduce postoperative kidney injury, but larger confirmatory randomized trials remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Age of 18 years or older; 2. Scheduled to undergo unilateral radical nephrectomy for renal cancer or unilateral radical nephroureterectomy for upper tract urothelial carcinoma. Exclusion criteria 1. Diagnosed with chronic kidney disease stage 4 or stage 5 (GFR\<30 ml/min/1.73m2) before surgery; 2. Uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg); 3. Combined with cardiovascular diseases with Revised Cardiac Risk Index (RCRI) \>1 or metabolic equivalents (METs) \<4; 4. Unable to communicate due to severe dementia, language barrier, or end-stage disease before surgery; 5. Other conditions that are considered unsuitable for inclusion (specific reasons should be indicated).
Where it's running
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Beijing University First Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
- Study coordinator: Dong-Xin Wang, MD,PhD
- Email: wangdongxin@hotmail.com
- Phone: 86 10 83572784
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.