Circulatory Management and Acute Kidney Injury in Patients Undergoing Partial Nephrectomy

Sponsor
Peking University First Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02803372
Collaborator
(none)
144
1
2
17
8.5

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Goal-directed circulatory management
  • Other: Routine circulatory management
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

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
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.

Active Comparator: Control group

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
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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of acute kidney injury after surgery [During the first 3 days after surgery]

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

Secondary Outcome Measures

  1. Serum creatinine concentration [At 3 and 6 months after surgery]

    Serum creatinine concentration

  2. Length of stay in hospital after surgery [From end of surgery to 30 days after surgery]

    Length of stay in hospital after surgery

  3. Incidence of postoperative complications [From end of surgery to 30 days after surgery]

    Incidence of complications within 30 days after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital Beijing Beijing China 100034

Sponsors and Collaborators

  • Peking University First Hospital

Investigators

  • Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dong-Xin Wang, Professor, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT02803372
Other Study ID Numbers:
  • 2016[1118]
First Posted:
Jun 17, 2016
Last Update Posted:
Jan 3, 2018
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Dong-Xin Wang, Professor, Peking University First Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 3, 2018