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Circulatory Management and Acute Kidney Injury in Patients Undergoing Partial Nephrectomy

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Goal-directed circulatory management
Routine circulatory management
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring partial nephrectomy, acute kidney injury, LiDCOrapid, circulatory management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of acute kidney injury after surgery
Acute kidney injury is diagnosed according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria

Secondary Outcome Measures

Serum creatinine concentration
Serum creatinine concentration
Length of stay in hospital after surgery
Length of stay in hospital after surgery
Incidence of postoperative complications
Incidence of complications within 30 days after surgery

Full Information

First Posted
June 6, 2016
Last Updated
December 30, 2017
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02803372
Brief Title
Circulatory Management and Acute Kidney Injury in Patients Undergoing Partial Nephrectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
partial nephrectomy, acute kidney injury, LiDCOrapid, circulatory management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Goal-directed circulatory management
Intervention Description
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 Type
Other
Intervention Name(s)
Routine circulatory management
Intervention Description
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 Outcome Measure Information:
Title
Incidence of acute kidney injury after surgery
Description
Acute kidney injury is diagnosed according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Time Frame
During the first 3 days after surgery
Secondary Outcome Measure Information:
Title
Serum creatinine concentration
Description
Serum creatinine concentration
Time Frame
At 3 and 6 months after surgery
Title
Length of stay in hospital after surgery
Description
Length of stay in hospital after surgery
Time Frame
From end of surgery to 30 days after surgery
Title
Incidence of postoperative complications
Description
Incidence of complications within 30 days after surgery
Time Frame
From end of surgery to 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data of individual participants for all primary and secondary outcome measures will be made available on request after study completion and paper publication.
Citations:
PubMed Identifier
26675951
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.
Results Reference
background
PubMed Identifier
16647477
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. doi: 10.1016/j.transproceed.2006.01.072.
Results Reference
background
PubMed Identifier
25948896
Citation
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.
Results Reference
background
PubMed Identifier
25583188
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.
Results Reference
background
PubMed Identifier
25498052
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.
Results Reference
background
PubMed Identifier
33658007
Citation
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.
Results Reference
derived

Learn more about this trial

Circulatory Management and Acute Kidney Injury in Patients Undergoing Partial Nephrectomy

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