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

NCT05149196 | Recruiting DMC

• 1 other identifier: 2021-417
• Study Type: interventional
• Target: 1,724
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrectomy; Nephroureterectomy; Hemodynamic Management; Acute Kidney Injury; Chronic Kidney Diseases

Keywords

Nephrectomy; Nephroureterectomy; Hemodynamic Management; Acute Kidney Injury; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• Incidence of acute kidney injury (early primary outcome)

  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).

  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 Outcomes (6)

• Incidence of myocardial injury after noncardiac surgery (MINS) within 7 days after surgery

  Up to 7 days after surgery

• Incidence of delirium within 7 days after surgery

  Up to 7 days after surgery

• Incidence of surgical site infection within 30 days after surgery

  Up to 30 days after surgery

• Incidence of CKD within 3 months after surgery

  Up to 3 months after surgery

• Proportion of various grades of CKD at different timepoints

  Up to 2 years after surgery

Other Outcomes (7)

• AKI stage within 7 days after surgery

  Up to 7 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

  Up to 30 days after surgery

Study Arms (2)

Targeted blood pressure management

EXPERIMENTAL

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

Routine care

ACTIVE COMPARATOR

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

Interventions

Targeted hemodynamic management OTHER

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.

Targeted blood pressure management

Routine care OTHER

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.

Routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years or older;
• Scheduled to undergo unilateral radical nephrectomy for renal cancer or unilateral radical nephroureterectomy for upper tract urothelial carcinoma.

You may not qualify if:

• Diagnosed with chronic kidney disease stage 4 or stage 5 (GFR\<30 ml/min/1.73m2) before surgery;
• Uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
• Combined with 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;

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Beijing University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

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MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD,PhD

CONTACT

86 10 83572784; wangdongxin@hotmail.com

Qiongfang Wu, MD

CONTACT

86 83575138; wuqf91@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 8, 2021
• Study Start: February 10, 2025
• Primary Completion (Estimated): December 30, 2032
• Study Completion (Estimated): December 30, 2034
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)