Circulatory Management and Acute Kidney Injury in Patients Undergoing Partial Nephrectomy

NCT02803372 | Completed DMC

• 1 other identifier: 2016[1118]
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Kidney Injury

Keywords

partial nephrectomy; acute kidney injury; LiDCOrapid; circulatory management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Serum creatinine concentration

  At 3 and 6 months after surgery

• Length of stay in hospital after surgery

  From end of surgery to 30 days after surgery

• Incidence of postoperative complications

  From end of surgery to 30 days after surgery

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

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.

Intervention group

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.

Control group

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years;
• Planning to undergo partial nephrectomy;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (6)

• 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.

  PMID: 26675951 BACKGROUND

• 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. doi: 10.1016/j.transproceed.2006.01.072.

  PMID: 16647477 BACKGROUND

• 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.

  PMID: 25948896 BACKGROUND

• 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.

  PMID: 25583188 BACKGROUND

• 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.

  PMID: 25498052 BACKGROUND

• Wu QF, Kong H, Xu ZZ, Li HJ, Mu DL, Wang DX. Impact of goal-directed hemodynamic management on the incidence of acute kidney injury in patients undergoing partial nephrectomy: a pilot randomized controlled trial. BMC Anesthesiol. 2021 Mar 3;21(1):67. doi: 10.1186/s12871-021-01288-8.

  PMID: 33658007 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 17, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: October 1, 2017
• Last Updated: January 3, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)