Circulatory Management and Acute Kidney Injury in Patients Undergoing Partial Nephrectomy

Acute Kidney Injury Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803372
• Other study ID #: 2016[1118]
• Status: Completed
• Phase: N/A
• First received: June 6, 2016
• Last updated: December 30, 2017
• Start date: May 2016
• Est. completion date: October 2017

Study information

• Verified date: December 2017
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: October 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > 18 years;

2. Planning to undergo partial nephrectomy;

Exclusion Criteria:

1. Patients with renal function damage (chronic kidney disease stage 3-5) before surgery;

2. Patients with arrhythmia or aortic valve diseases (moderate or higher degree stenosis/regurgitation);

3. Patients who has participated in other trials.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• Goal-directed circulatory management
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
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.

Locations

Country	Name	City	State
China	Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Aulakh NK, Garg K, Bose A, Aulakh BS, Chahal HS, Aulakh GS. Influence of hemodynamics and intra-operative hydration on biochemical outcome of renal transplant recipients. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):174-9. doi: 10.4103/0970-9185.155144. — View Citation

Chin JH, Jun IG, Lee J, Seo H, Hwang GS, Kim YK. Can stroke volume variation be an alternative to central venous pressure in patients undergoing kidney transplantation? Transplant Proc. 2014 Dec;46(10):3363-6. doi: 10.1016/j.transproceed.2014.09.097. — View Citation

De Gasperi A, Narcisi S, Mazza E, Bettinelli L, Pavani M, Perrone L, Grugni C, Corti A. Perioperative fluid management in kidney transplantation: is volume overload still mandatory for graft function? Transplant Proc. 2006 Apr;38(3):807-9. — View Citation

O'Loughlin E, Ward M, Crossley A, Hughes R, Bremner AP, Corcoran T. Evaluation of the utility of the Vigileo FloTrac(™) , LiDCO(™) , USCOM and CardioQ(™) to detect hypovolaemia in conscious volunteers: a proof of concept study. Anaesthesia. 2015 Feb;70(2):142-9. doi: 10.1111/anae.12949. — View Citation

Rajan S, Babazade R, Govindarajan SR, Pal R, You J, Mascha EJ, Khanna A, Yang M, Marcano FD, Singh AK, Kaouk J, Turan A. Perioperative factors associated with acute kidney injury after partial nephrectomy. Br J Anaesth. 2016 Jan;116(1):70-6. doi: 10.1093/bja/aev416. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum creatinine concentration	Serum creatinine concentration	At 3 and 6 months after surgery
Secondary	Length of stay in hospital after surgery	Length of stay in hospital after surgery	From end of surgery to 30 days after surgery
Secondary	Incidence of postoperative complications	Incidence of complications within 30 days after surgery	From end of surgery to 30 days after surgery