Anesthesia and Acute Kidney Injury After Nephrectomy
Primary Purpose
Nephrectomy
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propofol
Desflurane
Sponsored by
About this trial
This is an interventional prevention trial for Nephrectomy focused on measuring Anesthesia, Propofol, Inhaled anesthetics, Acute kidney injury, Nephrectomy
Eligibility Criteria
Inclusion Criteria:
- Adults patients scheduled for elective open nephrectomy
Exclusion Criteria:
- Patients diagnosed with acute kidney injury preoperatively
- Patients who have chronic kidney disease over stage 5 (estimated glomerular filtration rate [eGFR] <15 ml/kg/1.73m2) or have regular hemodialysis preoperatively
Sites / Locations
- Hyun-Kyu YoonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TIVA group
Inhalation group
Arm Description
Patients receiving the total intravenous anesthesia using propofol
Patients receiving inhalation anesthesia using desflurane
Outcomes
Primary Outcome Measures
the incidence of acute kidney injury
acute kidney injury (diagnosed by AKIN criteria)
Secondary Outcome Measures
serum creatinine
postoperative result of serum creatinine
estimated glomerular filtration rate
postoperative result of estimated glomerular filtration rate
biomarker of renal injury
postoperative result of biomarker of renal injury
the incidence of postoperative complications
urine leakage, prolonged ileus, wound infection, retroperitoneal abscess, pneumonia, reoperation, etc.
Length of hospital stay
length of hospital stay
Length of intensive care unit stay
length of intensive care unit stay
Full Information
NCT ID
NCT04474600
First Posted
July 7, 2020
Last Updated
August 12, 2022
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04474600
Brief Title
Anesthesia and Acute Kidney Injury After Nephrectomy
Official Title
The Influence of Type of Anesthesia on Postoperative Renal Function After Nephrectomy: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study investigates the influence of type of anesthesia on postoperative renal dysfunction in patients undergoing nephrectomy. The participants will be allocated to either the group receiving the total intravenous anesthesia (TIVA) using propofol or the group receiving the inhaled anesthetics using desflurane.
Detailed Description
Nephrectomy is considered as a standard therapy for renal cell carcinoma, but it can cause postoperative renal dysfunction, such as acute kidney injury and chronic kidney disease. Therefore, it is imperative to identify modifiable risk factors for postoperative acute kidney injury after nephrectomy in advance. According to a recent retrospective study, total intravenous anesthesia using propofol is significantly associated with lower incidence of acute kidney injury after nephrectomy, compared to the inhalation anesthesia. However, there is no prospective study which investigates the influence of type of anesthesia on postoperative renal function after nephrectomy. Therefore, in the present study, we aimed to investigate the influence of type of anesthesia on acute kidney injury after nephrectomy by performing randomized controlled study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrectomy
Keywords
Anesthesia, Propofol, Inhaled anesthetics, Acute kidney injury, Nephrectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
324 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TIVA group
Arm Type
Experimental
Arm Description
Patients receiving the total intravenous anesthesia using propofol
Arm Title
Inhalation group
Arm Type
Active Comparator
Arm Description
Patients receiving inhalation anesthesia using desflurane
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
The induction and maintenance of anesthesia was performed by total intravenous anesthesia using propofol. In both groups, remifentanil is continuously infused throughout the surgery.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
The induction and maintenance of anesthesia was performed by inhalation anesthesia using desflurane. In both groups, remifentanil is continuously infused throughout the surgery.
Primary Outcome Measure Information:
Title
the incidence of acute kidney injury
Description
acute kidney injury (diagnosed by AKIN criteria)
Time Frame
during the postoperative seven days
Secondary Outcome Measure Information:
Title
serum creatinine
Description
postoperative result of serum creatinine
Time Frame
postoperative day 1, 3, 14
Title
estimated glomerular filtration rate
Description
postoperative result of estimated glomerular filtration rate
Time Frame
postoperative day 1, 3, 14
Title
biomarker of renal injury
Description
postoperative result of biomarker of renal injury
Time Frame
postoperative day 1, 3, 14
Title
the incidence of postoperative complications
Description
urine leakage, prolonged ileus, wound infection, retroperitoneal abscess, pneumonia, reoperation, etc.
Time Frame
during the postoperative two weeks
Title
Length of hospital stay
Description
length of hospital stay
Time Frame
during the postoperative two weeks
Title
Length of intensive care unit stay
Description
length of intensive care unit stay
Time Frame
during the postoperative two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults patients scheduled for elective open nephrectomy
Exclusion Criteria:
Patients diagnosed with acute kidney injury preoperatively
Patients who have chronic kidney disease over stage 5 (estimated glomerular filtration rate [eGFR] <15 ml/kg/1.73m2) or have regular hemodialysis preoperatively
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun-Kyu Yoon, MD
Phone
+821095188501
Ext
+82220720065
Email
hyunkyu18@gmail.com
Facility Information:
Facility Name
Hyun-Kyu Yoon
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun-Kyu Yoon, MD
Phone
02-2072-0065
Email
Hyunkyu18@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Anesthesia and Acute Kidney Injury After Nephrectomy
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