Nephrectomy,Kidney DonationNCT01549990
A Comparison of Kidney Function After Nephrectomy in Living Donors Under Sevoflurane and Desflurane Anesthesia
An observational study of Nephrectomy,Kidney Donation, run by Yonsei University at 1 site in South Korea.
Trial summary
Living-donor kidney transplantation has been considered as the best treatment for patients with end-stage renal disease (ESRD). Kidney donation from living donors has been performed widely under their noble humanity and a belief that donation would not harm the donor. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Nephrectomy,Kidney Donation
- What is being tested?
- Sevoflurane and desflurane
- How many people
- 236 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Oct 2012
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2006 through December 2011, donors who went through nephrectomy for kidney donation
Who may be able to join
- donors who went through nephrectomy for kidney donation under general anesthesia with sevoflurane or desflurane
Who cannot join
- donors who went through nephrectomy for kidney donation under general anesthesia with other inhaled anesthetics except sevoflurane and desflurane
Trial locations and contacts
1 site in 1 country.
About this study
Living-donor kidney transplantation has been considered as the best treatment for patients with end-stage renal disease (ESRD). Kidney donation from living donors has been performed widely under their noble humanity and a belief that donation would not harm the donor. Although the overall evidences proposed that living kidney donor have medical outcomes similar to those in general population, several reports have demonstrated the potential risks for development of hypertension, proteinuria, and ESRD. Thus, all efforts should be concentrated on ensuring their safety and preserving the function of their remained kidney during anesthesia maintenance.
Inhaled anesthetics have been frequently used for the induction and maintenance of general anesthesia. The metabolism of certain inhaled anesthetics can produce inorganic fluoride, which may be directly nephrotoxic through impairments of renal concentrating ability. The typical inhaled anesthetics commonly used nowadays are sevoflurane and desflurane. The defluorination of sevoflurane can results in increased serum inorganic fluoride ion concentrations, but any neprhotoxic effect of sevoflurane has not been proven yet in human. On the other hand, desflurane is extremely resistant to defluorination, and desflurane does not appear to be nephrotoxic.
The inhaled anesthetics which are currently used in general anesthesia have no clinical evidence of nephrotoxicity, but the possible risks cannot be excluded entirely, especially in the patients who one kidney is donated. The purpose of the current retrospective, single center study was to evaluate and compare postoperative renal function of living kidney donor after nephrectomy under sevoflurane or desflurane anesthesia, and make evidence-based recommendations of proper inhaled anesthetics for anesthesia of living kidney donor.
- Conditions
- Nephrectomy,Kidney Donation
- Being tested
- Sevoflurane, desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
maintenance of general anesthesia with sevoflurane
desfluraneDrug
maintenance of general anesthesia with desflurane
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane group | donors who went through donor nephrectomy under general anesthesia with sevoflurane Receives: Drug: Sevoflurane | |
| desflurane group | donors who went through donor nephrectomy under general anesthesia with desflurane Receives: Drug: desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative renal function of living kidney donor after nephrectomy under sevoflurane or desflurane anesthesia
We collect laboratory data of the patients which were underwent at preoperative period and during postoperative periods. The laboratory data includes hemoglobin (Hb), hematocrit (Hct), platelet, prothrombin time (PT), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine (Cr) and estimated glomerular filtration rate (eGFR) which was calculated by the Modification of Diet in Renal Disease (MDRD) formula with age, gender, race, and serum creatinine as variables.
Measured: Participants will be followed for postoperative period, approximate 1 week through chart review.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nephrectomy,Kidney DonationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549990
- Sponsor's protocol ID
- 4-2012-0012
- Status last verified
- Jan 2015
- First submitted
- 6 Mar 2012
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Vats HS, Rayhill SC, Thomas CP. Early postnephrectomy donor renal function: laparoscopic versus open procedure. Transplantation. 2005 Mar 15;79(5):609-12. doi: 10.1097/01.tp.0000151662.84962.4e.
PubMed 15753853
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Kidney Function After Nephrectomy in Living Donors Under Sevoflurane and Desflurane Anesthesia
- ClinicalTrials.gov ID
- NCT01549990
- Acronym / sponsor ID
- 4-2012-0012
- Conditions
- Nephrectomy,Kidney Donation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Mar 2012 (estimated)
- 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.
Living-donor kidney transplantation has been considered as the best treatment for patients with end-stage renal disease (ESRD). Kidney donation from living donors has been performed widely under their noble humanity and a belief that donation would not harm the donor. Although the overall evidences proposed that living kidney donor have medical outcomes similar to those in general population, several reports have demonstrated the potential risks for development of hypertension, proteinuria, and ESRD. Thus, all efforts should be concentrated on ensuring their safety and preserving the function of their remained kidney during anesthesia maintenance.
Inhaled anesthetics have been frequently used for the induction and maintenance of general anesthesia. The metabolism of certain inhaled anesthetics can produce inorganic fluoride, which may be directly nephrotoxic through impairments of renal concentrating ability. The typical inhaled anesthetics commonly used nowadays are sevoflurane and desflurane. The defluorination of sevoflurane can results in increased serum inorganic fluoride ion concentrations, but any neprhotoxic effect of sevoflurane has not been proven yet in human. On the other hand, desflurane is extremely resistant to defluorination, and desflurane does not appear to be nephrotoxic.
The inhaled anesthetics which are currently used in general anesthesia have no clinical evidence of nephrotoxicity, but the possible risks cannot be excluded entirely, especially in the patients who one kidney is donated. The purpose of the current retrospective, single center study was to evaluate and compare postoperative renal function of living kidney donor after nephrectomy under sevoflurane or desflurane anesthesia, and make evidence-based recommendations of proper inhaled anesthetics for anesthesia of living kidney donor.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane group | – | Drug: Sevofluranedonors who went through donor nephrectomy under general anesthesia with sevoflurane |
| desflurane group | – | Drug: desfluranedonors who went through donor nephrectomy under general anesthesia with desflurane |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2006 through December 2011, donors who went through nephrectomy for kidney donation
Key inclusion criteria (1 listed)
- donors who went through nephrectomy for kidney donation under general anesthesia with sevoflurane or desflurane
Key exclusion criteria (1 listed)
- donors who went through nephrectomy for kidney donation under general anesthesia with other inhaled anesthetics except sevoflurane and desflurane
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 |
|---|---|---|
| Sevofluranemaintenance of general anesthesia with sevoflurane | Drug | Sevoflurane group |
| desfluranemaintenance of general anesthesia with desflurane | Drug | desflurane group |
Primary outcome
Postoperative renal function of living kidney donor after nephrectomy under sevoflurane or desflurane anesthesia
Time frame: Participants will be followed for postoperative period, approximate 1 week through chart review.
We collect laboratory data of the patients which were underwent at preoperative period and during postoperative periods. The laboratory data includes hemoglobin (Hb), hematocrit (Hct), platelet, prothrombin time (PT), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine (Cr) and estimated glomerular filtration rate (eGFR) which was calculated by the Modification of Diet in Renal Disease (MDRD) formula with age, gender, race, and serum creatinine as variables.
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 27 Jan 2015.
- Background: PubMed 15753853Vats HS, Rayhill SC, Thomas CP. Early postnephrectomy donor renal function: laparoscopic versus open procedure. Transplantation. 2005 Mar 15;79(5):609-12. doi: 10.1097/01.tp.0000151662.84962.4e.
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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?
An observational study of Nephrectomy,Kidney Donation, run by Yonsei University 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 1 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 27 Jan 2015. 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?
Postoperative renal function of living kidney donor after nephrectomy under sevoflurane or desflurane anesthesia (time frame: Participants will be followed for postoperative period, approximate 1 week through chart review.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01549990, which also lists 1 linked publication.
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 27 Jan 2015.