Goal-directed blood pressure, fluid, and urine management to prevent kidney injury after kidney removal
Impact of Goal-directed Hemodynamic Management on Occurrence of Acute and Persistent Kidney Injury After Radical Nephrectomy or Nephroureterectomy: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1724 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05149196 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Preliminary trials and meta-analyses have suggested goal-directed hemodynamic management can reduce postoperative kidney injury, but larger confirmatory randomized trials remain limited.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.