NCT01549990

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

8 months

First QC Date

March 6, 2012

Last Update Submit

January 26, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Participants will be followed for postoperative period, approximate 1 week through chart review.

Study Arms (2)

Sevoflurane group

donors who went through donor nephrectomy under general anesthesia with sevoflurane

Drug: Sevoflurane

desflurane group

donors who went through donor nephrectomy under general anesthesia with desflurane

Drug: desflurane

Interventions

maintenance of general anesthesia with sevoflurane

Sevoflurane group

maintenance of general anesthesia with desflurane

desflurane group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From January 2006 through December 2011, donors who went through nephrectomy for kidney donation

You may qualify if:

  • donors who went through nephrectomy for kidney donation under general anesthesia with sevoflurane or desflurane

You may not qualify if:

  • donors who went through nephrectomy for kidney donation under general anesthesia with other inhaled anesthetics except sevoflurane and desflurane

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 15753853BACKGROUND

MeSH Terms

Interventions

SevofluraneDesflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 9, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations