Cancer statistics, 2020.
Rebecca L Siegel, Kimberly D Miller, Ahmedin Jemal
https://pubmed.ncbi.nlm.nih.gov/31912902Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05149196
Impact of Goal-directed Hemodynamic Management on Acute and Persistent Kidney Injury After Radical Nephrectomy or Nephroureterectomy
Led by Peking University First Hospital · Updated on 2025-06-03
1724
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of goal-directed hemodynamic management on kidney injury in patients undergoing radical nephrectomy or nephroureterectomy, surgeries performed for renal cell carcinoma and upper tract urothelial carcinoma. These surgeries often lead to acute kidney injury (AKI), which increases the risk of chronic kidney disease (CKD). This study aims to determine if managing blood flow and pressure during surgery can reduce AKI occurrence and improve long-term kidney health. The study compares two approaches during surgery: one group receives goal-directed hemodynamic management involving active hydration, inotropes (dobutamine), and forced diuresis to maintain specific targets for pulse pressure variation, mean arterial pressure, and urine output. The other group receives routine care with standard fluid infusion and blood pressure targets. Post-surgery, blood pressure is carefully managed for 48 hours in the goal-directed group, while routine care continues for the other group. Participants will be monitored for up to 7 days after surgery to assess the incidence of acute kidney injury, and for up to 2 years to evaluate new or worsening chronic kidney disease. Additional outcomes include heart injury, delirium, surgical site infections, and survival without major events. The study involves regular monitoring of vital signs, kidney function, and other health assessments during hospitalization and follow-up visits to evaluate the long-term effects of the different management approaches.
CONDITIONS
Brief Title
Goal-directed Hemodynamic Management and Kidney Injury After Radical Nephrectomy or Nephroureterectomy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age of 18 years or older
- Scheduled to undergo unilateral radical nephrectomy for renal cancer
- Scheduled to undergo unilateral radical nephroureterectomy for upper tract urothelial carcinoma
You will not qualify if you...
- Diagnosed with chronic kidney disease stage 4 or 5 (GFR <30 ml/min/1.73m2) before surgery
- Uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg)
- Combined cardiovascular diseases with Revised Cardiac Risk Index (RCRI) >1 or metabolic equivalents (METs) <4
- Unable to communicate due to severe dementia, language barrier, or end-stage disease before surgery
- Other conditions considered unsuitable for inclusion as specified by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day and first 48 hours after surgery
Participants undergo radical nephrectomy or nephroureterectomy surgery. During anesthesia, participants receive either targeted hemodynamic management involving active hydration, inotropes, and forced diuresis to maintain specific blood pressure and urine output targets, or routine care according to standard practice. Hemodynamic management continues during the first 48 hours after surgery.
1 surgical visit and hospital stay including post-operative care
Post-operative Follow-up
Duration - Up to 2 years after surgery
Participants are monitored for acute kidney injury, myocardial injury, delirium, and surgical site infections following surgery. Kidney function and possible chronic kidney disease progression are assessed over time.
Visits up to 7 days, 30 days, 3 months, and periodic assessments up to 2 years
Trial Site Locations
Total: 1 location
1
Beijing University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
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Research Team
D
Dong-Xin Wang, MD,PhD
Q
Qiongfang Wu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Prognostic factors and prognostic models for renal cell carcinoma: a literature review.
Tobias Klatte, Sabrina H Rossi, Grant D Stewart
https://pubmed.ncbi.nlm.nih.gov/29713755Post-operative acute kidney injury in patients with renal cell carcinoma is a potent risk factor for new-onset chronic kidney disease after radical nephrectomy.
Ajin Cho, Jung Eun Lee, Gee-Young Kwon...
https://pubmed.ncbi.nlm.nih.gov/21406544Effect of post-nephrectomy acute kidney injury on renal outcome: a retrospective long-term study.
Carlo Garofalo, Maria Elena Liberti, Domenico Russo...
https://pubmed.ncbi.nlm.nih.gov/29063267Risk factors for acute kidney injury after radical nephrectomy and inferior vena cava thrombectomy for renal cell carcinoma.
Sung Shin, Youngjin Han, Hojong Park...
https://pubmed.ncbi.nlm.nih.gov/23591189Acute kidney injury and chronic kidney disease as interconnected syndromes.
Lakhmir S Chawla, Paul W Eggers, Robert A Star...
https://pubmed.ncbi.nlm.nih.gov/24988558Long-term risk of adverse outcomes after acute kidney injury: a systematic review and meta-analysis of cohort studies using consensus definitions of exposure.
Emily J See, Kushani Jayasinghe, Neil Glassford...
https://pubmed.ncbi.nlm.nih.gov/30473140Mild Acute Kidney Injury after Noncardiac Surgery Is Associated with Long-term Renal Dysfunction: A Retrospective Cohort Study.
Alparslan Turan, Barak Cohen, Janet Adegboye...
https://pubmed.ncbi.nlm.nih.gov/31929326Robust Association between Acute Kidney Injury after Radical Nephrectomy and Long-term Renal Function.
Won Ho Kim, Kyung Won Shin, Sang-Hwan Ji...
https://pubmed.ncbi.nlm.nih.gov/32106477Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension.
Michael Walsh, Philip J Devereaux, Amit X Garg...
https://pubmed.ncbi.nlm.nih.gov/23835589