NephrectomyNCT04474600
Anesthesia and Acute Kidney Injury After Nephrectomy
A study testing Propofol and Desflurane in people with Nephrectomy, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrectomy
- What is being tested?
- Propofol and Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2020to 6 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults patients scheduled for elective open nephrectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nephrectomy
- Being tested
- Propofol, Desflurane
- Keywords
- Anesthesia, Propofol, Inhaled anesthetics, Acute kidney injury, Nephrectomy
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
The induction and maintenance of anesthesia was performed by total intravenous anesthesia using propofol. In both groups, remifentanil is continuously infused throughout the surgery.
DesfluraneDrug
The induction and maintenance of anesthesia was performed by inhalation anesthesia using desflurane. In both groups, remifentanil is continuously infused throughout the surgery.
| Study group | Role | What they receive |
|---|---|---|
| TIVA group | Experimental | Patients receiving the total intravenous anesthesia using propofol Receives: Drug: Propofol |
| Inhalation group | Active comparator | Patients receiving inhalation anesthesia using desflurane Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of acute kidney injury
acute kidney injury (diagnosed by KDIGO criteria)
Measured: during the postoperative seven days
Secondary outcomes (6)
serum creatinine
postoperative result of serum creatinine
Measured: postoperative day 1, 3, 14
estimated glomerular filtration rate
postoperative result of estimated glomerular filtration rate
Measured: postoperative day 1, 3, 14
biomarker of renal injury
postoperative result of biomarker of renal injury
Measured: postoperative day 1, 3, 14
the incidence of postoperative complications
urine leakage, prolonged ileus, wound infection, retroperitoneal abscess, pneumonia, reoperation, etc.
Measured: during the postoperative two weeks
Length of hospital stay
length of hospital stay
Measured: during the postoperative two weeks
Length of intensive care unit stay
length of intensive care unit stay
Measured: during the postoperative two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start20 Jul 2020
- Primary completion6 Feb 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrectomyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Kyu Yoon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474600
- Sponsor's protocol ID
- Anesthetics_Nx_AKI
- Status last verified
- Nov 2024
- First submitted
- 7 Jul 2020
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Type of Anesthesia on Postoperative Renal Function After Nephrectomy: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04474600
- Acronym / sponsor ID
- Anesthetics_Nx_AKI
- Conditions
- Nephrectomy
- Keywords
- Anesthesia, Propofol, Inhaled anesthetics, Acute kidney injury, Nephrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA group | Experimental | Drug: PropofolPatients receiving the total intravenous anesthesia using propofol |
| Inhalation group | Active comparator | Drug: DesfluranePatients receiving inhalation anesthesia using desflurane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults patients scheduled for elective open nephrectomy
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolThe induction and maintenance of anesthesia was performed by total intravenous anesthesia using propofol. In both groups, remifentanil is continuously infused throughout the surgery. | Drug | TIVA group |
| DesfluraneThe induction and maintenance of anesthesia was performed by inhalation anesthesia using desflurane. In both groups, remifentanil is continuously infused throughout the surgery. | Drug | Inhalation group |
Primary outcome
the incidence of acute kidney injury
Time frame: during the postoperative seven days
acute kidney injury (diagnosed by KDIGO criteria)
6 secondary outcomes
serum creatinine
Time frame: postoperative day 1, 3, 14
estimated glomerular filtration rate
Time frame: postoperative day 1, 3, 14
biomarker of renal injury
Time frame: postoperative day 1, 3, 14
the incidence of postoperative complications
Time frame: during the postoperative two weeks
Length of hospital stay
Time frame: during the postoperative two weeks
Length of intensive care unit stay
Time frame: during the postoperative two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Desflurane in people with Nephrectomy, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of acute kidney injury (time frame: during the postoperative seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.