- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04474600
Anesthesia and Acute Kidney Injury After Nephrectomy
November 27, 2024 updated by: Hyun-Kyu Yoon, Seoul National University Hospital
The Influence of Type of Anesthesia on Postoperative Renal Function After Nephrectomy: a Randomized Controlled Study
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
324
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TIVA group
Patients receiving the total intravenous anesthesia using propofol
|
The induction and maintenance of anesthesia was performed by total intravenous anesthesia using propofol.
In both groups, remifentanil is continuously infused throughout the surgery.
|
|
Active Comparator: Inhalation group
Patients receiving inhalation anesthesia using desflurane
|
The induction and maintenance of anesthesia was performed by inhalation anesthesia using desflurane.
In both groups, remifentanil is continuously infused throughout the surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the incidence of acute kidney injury
Time Frame: during the postoperative seven days
|
acute kidney injury (diagnosed by KDIGO criteria)
|
during the postoperative seven days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
serum creatinine
Time Frame: postoperative day 1, 3, 14
|
postoperative result of serum creatinine
|
postoperative day 1, 3, 14
|
|
estimated glomerular filtration rate
Time Frame: postoperative day 1, 3, 14
|
postoperative result of estimated glomerular filtration rate
|
postoperative day 1, 3, 14
|
|
biomarker of renal injury
Time Frame: postoperative day 1, 3, 14
|
postoperative result of biomarker of renal injury
|
postoperative day 1, 3, 14
|
|
the incidence of postoperative complications
Time Frame: during the postoperative two weeks
|
urine leakage, prolonged ileus, wound infection, retroperitoneal abscess, pneumonia, reoperation, etc.
|
during the postoperative two weeks
|
|
Length of hospital stay
Time Frame: during the postoperative two weeks
|
length of hospital stay
|
during the postoperative two weeks
|
|
Length of intensive care unit stay
Time Frame: during the postoperative two weeks
|
length of intensive care unit stay
|
during the postoperative two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2020
Primary Completion (Actual)
February 6, 2024
Study Completion (Actual)
March 6, 2024
Study Registration Dates
First Submitted
July 7, 2020
First Submitted That Met QC Criteria
July 14, 2020
First Posted (Actual)
July 17, 2020
Study Record Updates
Last Update Posted (Estimated)
December 2, 2024
Last Update Submitted That Met QC Criteria
November 27, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Renal Insufficiency
- Acute Kidney Injury
- Physiological Effects of Drugs
- Anesthetics
- Central Nervous System Depressants
- Hypnotics and Sedatives
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics, Inhalation
- Desflurane
- Propofol
Other Study ID Numbers
- Anesthetics_Nx_AKI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nephrectomy
-
270SurgicalNot yet recruitingLaparoscopy | Nephrectomy | Partial NephrectomyIsrael
-
EgymedicalpediaCompleted
-
Namik Kemal UniversityCompleted
-
Benha UniversityCompleted
-
University of GaziantepCompletedLaparoscopic NephrectomyTurkey (Türkiye)
-
Indonesia UniversityCompletedLaparoscopic NephrectomyIndonesia
-
University of RochesterCompleted
Clinical Trials on Propofol
-
Nurdan SağbaşActive, not recruitingMajor Depression | Bipolar Affective Disorder | Bipolar Depression Depressed PhaseTurkey (Türkiye)
-
Groupe Hospitalier Diaconesses Croix Saint-SimonCompletedOocyte Retrieval | Medically Assisted Procreation (MAP)France
-
Marmara University Pendik Training and Research...Not yet recruitingEndoscopic Submucosal Dissection | Respiratory Complications | Target Controlled Infusion of Propofol | Endoscopy Unit
-
Hacettepe UniversityRecruitingSedation | Target Controlled Infusion of Propofol | Intensive Care Unit SedationTurkey (Türkiye)
-
Hopital FochCompleted
-
Stanford UniversityTiny Blue Dot FoundationEnrolling by invitationHealthy VolunteersUnited States
-
Istanbul University - CerrahpasaRecruitingAtrial Fibrillation | Deep Sedation | Electric CountershockTurkey (Türkiye)
-
Konkuk University Medical CenterCompletedCoronary Artery Disease | Valvular Heart DiseaseKorea, Republic of
-
Istanbul UniversityRecruitingTotal Intravenous Anesthesia | Spinal (Fusion) Surgery | Target Controlled Infusion of Propofol | BIS-EEG | Anesthesia Depth MonitoringTurkey (Türkiye)
-
University Medical Center GroningenCompletedAnesthesia | Hemodynamic Instability | Interaction | Disorder of Oxygen TransportNetherlands