Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Comparison of Kidney Function After Nephrectomy in Living Donors Under Sevoflurane and Desflurane Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01549990
First received: March 6, 2012
Last updated: March 11, 2012
Last verified: March 2012

March 6, 2012
March 11, 2012
February 2012
October 2012   (final data collection date for 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. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01549990 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Comparison of Kidney Function After Nephrectomy in Living Donors Under Sevoflurane and Desflurane Anesthesia
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

Nephrectomy,Kidney Donation
  • Drug: Sevoflurane
    maintenance of general anesthesia with sevoflurane
  • Drug: desflurane
    maintenance of general anesthesia with desflurane
  • Sevoflurane group
    donors who went through donor nephrectomy under general anesthesia with sevoflurane
    Intervention: Drug: Sevoflurane
  • desflurane group
    donors who went through donor nephrectomy under general anesthesia with desflurane
    Intervention: Drug: desflurane
Vats HS, Rayhill SC, Thomas CP. Early postnephrectomy donor renal function: laparoscopic versus open procedure. Transplantation. 2005 Mar 15;79(5):609-12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
236
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • donors who went through nephrectomy for kidney donation under general anesthesia with other inhaled anesthetics except sevoflurane and desflurane
Both
20 Years to 70 Years
No
Contact: Seung Ho Choi, Ph.D 82-2-2228-2429 csho99@yuhs.ac
Korea, Republic of
 
NCT01549990
4-2012-0012
No
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP