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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age of 18 years or older;

Scheduled to undergo unilateral radical nephrectomy for renal cancer or unilateral radical nephroureterectomy for upper tract urothelial carcinoma.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Targeted hemodynamic management

    Other intervention

    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.

  • Routine care

    Other intervention

    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.

Treatment groups

1,724 Participants
are divided into 2 treatment groups
Group A: Targeted blood pressure managementExperimental treatment 1 intervention
Group B: Routine careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 7 days after surgery
2

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.

Time frame
Up to 2 years after surgery

Secondary outcomes

1

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

MINS is diagnosed according to the Fourth Universal Definition of Myocardial Infarction (2018).

Time frame
Up to 7 days after surgery
2

Incidence of delirium within 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).

Time frame
Up to 7 days after surgery
3

Incidence of surgical site infection within 30 days after surgery

Surgical site infection is diagnosed according to predefined definition.

Time frame
Up to 30 days after surgery
4

Incidence of CKD within 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.

Time frame
Up to 3 months after surgery

Other outcomes

1

AKI stage within 7 days after surgery

Acute kidney injury is diagnosed and classified according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria.

Time frame
Up to 7 days after surgery
2

Proportion of patients admitted in intensive care unit after surgery

Proportion of patients admitted in intensive care unit after surgery.

Time frame
Up to 30 days after surgery
3

Incidence of other major postoperative complications

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.

Time frame
Up to 30 days after surgery
4

Length of hospital stay after surgery

Length of hospital stay after surgery

Time frame
Up to 30 days after surgery

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