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Clinical Trials/NCT02559297
NCT02559297
Completed
Phase 2

Effects of Sevoflurane and Desflurane Anesthesia on Regulatory T Cells in Patients Undergoing Living Donor Kidney Transplantation

Mahidol University1 site in 1 country40 target enrollmentAugust 10, 2015

Overview

Phase
Phase 2
Intervention
Sevoflurane
Conditions
Transplant; Failure, Kidney
Sponsor
Mahidol University
Enrollment
40
Locations
1
Primary Endpoint
Number of regulatory T cells
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This prospective interventional study aims to compare sevoflurane and desflurane anesthetic agents on regulatory T cell (Treg) numbers and its cytokine production in patients undergoing Living Donor Kidney Transplant (LDKT).

Detailed Description

All patients with end stage renal disease (ESRD) need renal replacement therapy, either dialysis or kidney transplantation. Dialysis, despite its effectiveness in prolonging ESRD patients' lives, is a burden. Successfulness in kidney transplantation will restore good quality of life in ESRD patients. However, one of the most important complications that lead to transplant failure is graft rejection. It is already known that the pathophysiology of the rejection is immune response. Recent evidence showed that regulatory T cell (Treg) plays a central role in preventing graft rejection by inhibiting recipient alloimmune response (1-3). Characterization of Treg numbers and/or functional changes under various conditions may lead to a new preventive measure and/or a novel therapeutic strategy for graft rejection. Kidney transplantation is conducted under general anesthesia. Interestingly, several agents used in general anesthesia have also modulated immune functions (4-12). Although the effect of inhalation anesthetic agents on leukocyte count has been shown, the effect on Treg function has totally been unknown. Knowing the effects of inhalation agents on Treg numbers and functions will be beneficial to intraoperative management during transplant surgery, aiming toward reducing the risk of graft rejection in the future.

Registry
clinicaltrials.gov
Start Date
August 10, 2015
End Date
June 3, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arpa Chutipongtanate

Faculty Member

Mahidol University

Eligibility Criteria

Inclusion Criteria

  • Patients receiving 1st living donor kidney transplantation

Exclusion Criteria

  • Hyperacute graft rejection
  • Pre-existing autoimmune or immunodeficiency diseases in recipients
  • Receiving blood product during 24-h perioperative period
  • Patient refuse to participate this study at any time point

Arms & Interventions

Sevoflurane

In sevoflurane arm (n=20) at the beginning after successful intubation, 2 L/min nitric oxide (N2O), 2 L/min O2 , and 2% to 2.5% sevoflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 minimal alveolar concentration (MAC) of sevoflurane in 50% O2 and 50% N2O.

Intervention: Sevoflurane

Desflurane

In desflurane arm (n=20) at the beginning after successful intubation, 2 L/min N2O, 2 L/min O2, and 6% to 8% desflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 MAC of desflurane in 50% O2 and 50% N2O.

Intervention: Desflurane

Outcomes

Primary Outcomes

Number of regulatory T cells

Time Frame: Within 24-h peri-operative period

Assessing change of Treg numbers by flow cytometry from baseline (before exposure to sevoflurane or desflurane) to after exposure to sevoflurane or desflurane for 2-h and 24-h

Secondary Outcomes

  • T lymphocyte cytokine production(Within 24-h peri-operative period)

Study Sites (1)

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