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NCT Number: NCT02803372

Circulatory Management and Acute Kidney Injury in Patients Undergoing 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

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Goal-directed circulatory management

Other

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.

Routine circulatory management

Other

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.

Primary outcomes

  1. Incidence of acute kidney injury after surgery

    Time frame: During the first 3 days after surgery

    Acute kidney injury is diagnosed according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria

Secondary outcomes

  1. Serum creatinine concentration

    Time frame: At 3 and 6 months after surgery

    Serum creatinine concentration

  2. Length of stay in hospital after surgery

    Time frame: From end of surgery to 30 days after surgery

    Length of stay in hospital after surgery

  3. Incidence of postoperative complications

    Time frame: From end of surgery to 30 days after surgery

    Incidence of complications within 30 days after surgery

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jun 17, 2016
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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