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

June 2, 2025 updated by: Dong-Xin Wang, Peking University First Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Renal cancer accounts for 20.3% of urinary system tumors, and the incidence is still increasing. Surgical resection is the main treatment of renal cancer; radical nephrectomy is the standard operation for renal cancer of stage T2 or above. For upper tract urothelial carcinoma (UTUC) which includes renal pelvis cancer and ureteral cancer, radical nephroureterectomy is the gold standard treatment. Both procedures involve the removal of one kidney. Acute kidney injury (AKI) is a common complication after radical nephrectomy and nephroureterectomy, with reported incidence from 53.9% to 72.7%. AKI is associated with the development of chronic kidney disease (CKD) and is an independent risk factor of new onset CKD in patients without underlying kidney disease. A meta-analysis showed that, at one year after surgery, patients with AKI had a 2.7-fold increased risk of new onset or progression of CKD and a 4.8-fold increased risk of end-stage renal disease. Moreover, even mild AKI is associated with renal insufficiency at 1 to 2 years after surgery.

Taking active measures to reduce the incidence of AKI may improve long-term renal function after radical nephrectomy and nephroureterectomy. Many clinical studies show that intraoperative hypotension is an important risk factor of postoperative kidney injury. For example, a study found that intraoperative mean arterial pressure (MAP) <65 mmHg or a decrease of more than 20% from baseline was associated with an increased risk of postoperative AKI; the risk of AKI increased alone with prolonged duration of hypotension. However, recent randomized controlled trials showed inconsistent results regarding the effect of tight blood pressure management strategy on kidney outcome. Relevant studies indicated that hydration with forced diuresis and inotropes to maintain cardiac output and blood pressure might improve renal outcome.

In a previous pilot trial of the authors, goal-directed hemodynamic management combining hydration and inotropics reduced the incidence of AKI by about 40% in patients following partial nephrectomy. However, the difference was not statistically significant due to insufficient sample size. The purpose of this trial is to investigate whether goal-directed intraoperative hemodynamic management combining hydration, inotropics, and forced diuresis can reduce the occurrence of acute and persistent kidney injury in patients undergoing radical nephrectomy and nephroureterectomy.

Study Type

Interventional

Enrollment (Estimated)

1724

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Qiongfang Wu, MD
  • Phone Number: 86 83575138
  • Email: wuqf91@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Beijing University First Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Targeted 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.
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.
Other: Routine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute kidney injury (early primary outcome)
Time Frame: Up to 7 days after surgery
Acute kidney injury is diagnosed and classified according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria. Acute kidney injury of stage 1 or above is defined as occurrence of acute kidney injury.
Up to 7 days after surgery
Time to new-onset or progression of chronic kidney disease (CKD) (long-term primary outcome).
Time Frame: Up to 2 years after surgery
New-onset CKD is defined as a decrease of glomerular filtration rate to <60 ml/min/1.73 m2 and persists for more than 3 months. Progression of CKD is defined as a decrease of glomerular filtration rate of 40% or more from baseline and persists for more than 3 months.
Up to 2 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of myocardial injury after noncardiac surgery (MINS) within 7 days after surgery
Time Frame: Up to 7 days after surgery
MINS is diagnosed according to the Fourth Universal Definition of Myocardial Infarction (2018).
Up to 7 days after surgery
Incidence of delirium within 7 days after surgery
Time Frame: Up to 7 days after surgery
Delirium is assessed twice daily with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or the 3-minute Diagnostic Interview for Confusion Assessment Method (3D-CAM).
Up to 7 days after surgery
Incidence of surgical site infection within 30 days after surgery
Time Frame: Up to 30 days after surgery
Surgical site infection is diagnosed according to predefined definition.
Up to 30 days after surgery
Incidence of CKD within 3 months after surgery
Time Frame: Up to 3 months after surgery
Included new-onset or progression of CKD. New-onset CKD is defined as a decrease of glomerular filtration rate to <60 ml/min/1.73 m2 and persists for more than 3 months. Progression of CKD is defined as a decrease of glomerular filtration rate of 40% or more from baseline and persists for more than 3 months.
Up to 3 months after surgery
Proportion of various grades of CKD at different timepoints
Time Frame: Up to 2 years after surgery
CKD is diagnosed and classified according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Up to 2 years after surgery
Event-free survival
Time Frame: Up to 2 years after surgery
Time interval from the end of surgery to new-onset or progression of CKD, serious events (required hospitalization or reoperation), or all-cause death, which ever come first. New-onset CKD is defined as a decrease of glomerular filtration rate to <60 ml/min/1.73 m2 and persists for more than 3 months. Progression of CKD is defined as a decrease of glomerular filtration rate of 40% or more from baseline and persists for more than 3 months.
Up to 2 years after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay after surgery
Time Frame: Up to 30 days after surgery
Length of hospital stay after surgery
Up to 30 days after surgery
AKI stage within 7 days after surgery
Time Frame: Up to 7 days after surgery
Acute kidney injury is diagnosed and classified according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Up to 7 days after surgery
Proportion of patients admitted in intensive care unit after surgery
Time Frame: Up to 30 days after surgery
Proportion of patients admitted in intensive care unit after surgery.
Up to 30 days after surgery
Incidence of other major postoperative complications
Time Frame: Up to 30 days after surgery
Major postoperative complications are defined as new-onset medical conditions that are harmful to patients' recovery and required therapeutic intervention, i.e., grade 2 or higher on the Clavien-Dindo classification.
Up to 30 days after surgery
Overall survival time
Time Frame: Up to 2 years after surgery
Time interval from the end of surgery to all-cause death.
Up to 2 years after surgery
Prevalence of neurocognitive disorder at 6 months and 1 year after surgery
Time Frame: At 6 months and 1 year after surgery
Neurocognitive disorder is defined as a decrease of neurocognitive function score of 1 standard deviation (SD) or more from baseline. Neurocognitive function is assessed with the Montreal Cognitive Assessment-telephone version (T-MoCA; score ranges from 0 to 22, with higher score indicating better cognitive function).
At 6 months and 1 year after surgery
Quality of life at 6 months and 1 year after surgery
Time Frame: At 6 months and 1 year after surgery
Quality of life is assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF), a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function.
At 6 months and 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

December 30, 2032

Study Completion (Estimated)

December 30, 2034

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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