Circulatory Management and Acute Kidney Injury in Patients Undergoing Partial Nephrectomy

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether circulatory management based on LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients undergoing partial nephrectomy when compared with routine circulatory management based on blood pressure and urine output monitoring

Detailed Description
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Previous studies found that the incidence of acute kidney injury afer partial nephrectomy is higher than 30%. In addition to nephron loss induced by renal parenchyma resection, ischemia/reperfusion injury produced by clamping/unclamping of renal arteries is also an important reason. However, studies investigating the effect of circulatory management on the incidence of acute kidney injury after partial nephrectomy are limited. It has been shown that perioperative hemodynamic optimization protected renal function in surgical patients. And in patients undergoing renal transplantation, adequate hydration and optimal perfusion enhances early graft function. The investigators hypothesize that hydration and circulatory management to guarantee optimal renal perfusion may decrease the occurrence of acute kidney injury after partial nephrectomy. The purpose of this study is to investigate whether circulatory management based on LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients undergoing partial nephrectomy when compared with routine circulatory management based on blood pressure and urine output monitoring.

Official Title
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Impact of Circulatory Management Based on LiDCOrapid Hemodynamic Monitoring on the Incidence of Acute Kidney Injury in Patients Undergoing Partial Nephrectomy: A Randomized Controlled Trial

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Other: Goal-directed circulatory management
* Other: Routine circulatory management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years; Planning to undergo partial nephrectomy; Exclusion Criteria: Patients with renal function damage (chronic kidney disease stage 3-5) before surgery; Patients with arrhythmia or aortic valve diseases (moderate or higher degree stenosis/regurgitation); Patients who has participated in other trials.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>In addition to routine monitoring, invasive LiDCOrapid is used to monitor mean arterial pressure (MAP), stroke volume variation (SVV) and cardiac index (CI). Intraoperative goal-directed circulatory management is performed, i.e., to maintain MAP > 95 mmHg, SVV < 6%, and CI 3.0-4.0 L/min/m2, started from renal artery clamping and maintained until the end of surgery. | Other: Goal-directed circulatory management<br>* In addition to routine monitoring, invasive LiDCOrapid is used to monitor MAP, SVV and CI. Intraoperative circulatory management is performed according to the goal-directed principal, i.e., to maintain MAP > 95 mmHg, SVV < 6%, and CI 3.0-4.0 L/min/m2, started from renal artery clamping and maintained until the end of surgery. Crystalloid solution is firstly infused to maintain SVV at the target level, dobutamine and/or noradrenaline are then infused to maintain MAP and CI at the target levels.<br>|
| Active Comparator: Control group<br>Routine monitoring is performed, which includes invasive blood pressure and urine output. Intraoperative routine circulatory management is performed, i.e., to maintain blood pressure within 20% from baseline level and urine output > 0.5 ml/kg/h. | Other: Routine circulatory management<br>* Routine monitoring is performed, which include invasive blood pressure and urine output. Intraoperative circulatory management is performed according to routine practice, i.e., to maintain blood pressure within 20% from baseline level and urine output > 0.5 ml/kg/h by infusing crystalloid solution and administering vasoactive drugs when considered necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute kidney injury after surgery | Acute kidney injury is diagnosed according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria | During the first 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine concentration | Serum creatinine concentration | At 3 and 6 months after surgery | 
| Length of stay in hospital after surgery | Length of stay in hospital after surgery | From end of surgery to 30 days after surgery | 
| Incidence of postoperative complications | Incidence of complications within 30 days after surgery | From end of surgery to 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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partial nephrectomy, acute kidney injury, LiDCOrapid, circulatory management