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Transplant; Failure, KidneyPhase 2NCT02559297

Effects of Sevoflurane and Desflurane on Treg

A Phase 2 study testing Sevoflurane and Desflurane in people with Transplant; Failure, Kidney, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transplant; Failure, Kidney
What is being tested?
Sevoflurane and Desflurane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteThailand
Study dates
10 Aug 2015to 3 Jun 2017
Phase
Phase 2
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

  • Patients receiving 1st living donor kidney transplantation

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Ramathibodi Hospital

    Ratchathewi, Bangkok, 10400

Other trials in Thailand

About this study

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

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).

Read the 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.

Being tested
Sevoflurane, Desflurane
Keywords
Regulatory T cells, Sevoflurane, Desflurane, Cytokines, Flow cytometry, Living Donor Kidney Transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SevofluraneDrug

    Also called Ultane

    After induction of anesthesia and successful intubation, 2 L/min 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. Ventilation will be adjusted to keep end-tidal carbon dioxide 30-35 mmHg (Tidal volume 7-10 mL/kg).

  • DesfluraneDrug

    Also called Suprane

    After induction of anesthesia and 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 minimal alveolar concentration (MAC) of desflurane in 50% O2 and 50% N2O. Ventilation will be adjusted to keep end-tidal carbon dioxide 30-35 mmHg (Tidal volume 7-10 mL/kg).

Study groups in NCT02559297
Study groupRoleWhat they receive
SevofluraneActive comparatorIn 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.
Receives: Drug: Sevoflurane
DesfluraneExperimentalIn 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.
Receives: Drug: Desflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of regulatory T cells

    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

    Measured: Within 24-h peri-operative period

Secondary outcomes (1)

  1. T lymphocyte cytokine production

    Assessing change of T lymphocyte cytokine production using Multiplex immunoassay of interleukin (IL)-10, Tumor Necrosis Factor (TGF)-beta, IL-2, Interferon (IFN)-gamma, IL-4, IL-5, IL-13, from baseline (before exposure to sevoflurane or desflurane) to after exposure to sevoflurane or desflurane for 2-h and 24-h

    Measured: Within 24-h peri-operative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2015 (estimated)
  2. Study start10 Aug 2015
  3. Primary completion3 Jun 2017
  4. Study completion3 Jun 2017

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02559297
Sponsor's protocol ID
04-58-23
Status last verified
Jun 2017
First submitted
22 Sep 2015
Last updated
15 Jun 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Data is obtained by flow cytometry and multiplex immunoassay. The data includes percentages of regulatory T cells and the measured cytokines. The data will be available in the end of study period, 05/2017.

Publications

  • Edozie FC, Nova-Lamperti EA, Povoleri GA, Scotta C, John S, Lombardi G, Afzali B. Regulatory T-cell therapy in the induction of transplant tolerance: the issue of subpopulations. Transplantation. 2014 Aug 27;98(4):370-9. doi: 10.1097/TP.0000000000000243.

    PubMed 24933458

  • San Segundo D, Millan O, Munoz-Cacho P, Boix F, Paz-Artal E, Talayero P, Morales JM, Muro M, De Cos MA, Guirado L, Llorente S, Pascual J, Arias M, Brunet M, Lopez-Hoyos M. High proportion of pretransplantation activated regulatory T cells (CD4+CD25highCD62L+CD45RO+) predicts acute rejection in kidney transplantation: results of a multicenter study. Transplantation. 2014 Dec 15;98(11):1213-8. doi: 10.1097/TP.0000000000000202.

    PubMed 25083613

  • Lopez-Hoyos M, Segundo DS, Fernandez-Fresnedo G, Marin MJ, Gonzalez-Martin V, Arias M. Regulatory T cells in renal transplantation and modulation by immunosuppression. Transplantation. 2009 Aug 15;88(3 Suppl):S31-9. doi: 10.1097/TP.0b013e3181af7b99.

    PubMed 19667959

  • Zhang T, Fan Y, Liu K, Wang Y. Effects of different general anaesthetic techniques on immune responses in patients undergoing surgery for tongue cancer. Anaesth Intensive Care. 2014 Mar;42(2):220-7. doi: 10.1177/0310057X1404200209.

    PubMed 24580388

  • Schneemilch CE, Hachenberg T, Ansorge S, Ittenson A, Bank U. Effects of different anaesthetic agents on immune cell function in vitro. Eur J Anaesthesiol. 2005 Aug;22(8):616-23. doi: 10.1017/s0265021505001031.

    PubMed 16119599

  • Ji FH, Wang YL, Yang JP. Effects of propofol anesthesia and sevoflurane anesthesia on the differentiation of human T-helper cells during surgery. Chin Med J (Engl). 2011 Feb;124(4):525-9.

    PubMed 21362275

  • Pirbudak Cocelli L, Ugur MG, Karadasli H. Comparison of effects of low-flow sevoflurane and desflurane anesthesia on neutrophil and T-cell populations. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):41-51. doi: 10.1016/j.curtheres.2012.02.005.

    PubMed 24653511

  • Loop T, Dovi-Akue D, Frick M, Roesslein M, Egger L, Humar M, Hoetzel A, Schmidt R, Borner C, Pahl HL, Geiger KK, Pannen BH. Volatile anesthetics induce caspase-dependent, mitochondria-mediated apoptosis in human T lymphocytes in vitro. Anesthesiology. 2005 Jun;102(6):1147-57. doi: 10.1097/00000542-200506000-00014.

    PubMed 15915027

  • Hisano T, Namba T, Hashiguchi-Ikeda M, Ito T, Hirota K, Fukuda K. Inhibition of E-selectin-mediated leukocyte adhesion by volatile anesthetics in a static condition. J Anesth. 2005;19(1):1-6. doi: 10.1007/s00540-004-0274-0.

    PubMed 15674507

  • Koksoy S, Sahin Z, Karsli B. Comparison of the effects of desflurane and bupivacaine on Th1 and Th2 responses. Clin Lab. 2013;59(11-12):1215-20. doi: 10.7754/clin.lab.2013.120413.

    PubMed 24409654

  • Kim WH, Jin HS, Ko JS, Hahm TS, Lee SM, Cho HS, Kim MH. The effect of anesthetic techniques on neutrophil-to-lymphocyte ratio after laparoscopy-assisted vaginal hysterectomy. Acta Anaesthesiol Taiwan. 2011 Sep;49(3):83-7. doi: 10.1016/j.aat.2011.08.004. Epub 2011 Sep 22.

    PubMed 21982167

  • Zhou D, Gu FM, Gao Q, Li QL, Zhou J, Miao CH. Effects of anesthetic methods on preserving anti-tumor T-helper polarization following hepatectomy. World J Gastroenterol. 2012 Jun 28;18(24):3089-98. doi: 10.3748/wjg.v18.i24.3089.

    PubMed 22791944

  • Chutipongtanate A, Prukviwat S, Pongsakul N, Srisala S, Kamanee N, Arpornsujaritkun N, Gesprasert G, Apiwattanakul N, Hongeng S, Ittichaikulthol W, Sumethkul V, Chutipongtanate S. Effects of Desflurane and Sevoflurane anesthesia on regulatory T cells in patients undergoing living donor kidney transplantation: a randomized intervention trial. BMC Anesthesiol. 2020 Aug 27;20(1):215. doi: 10.1186/s12871-020-01130-7.

    PubMed 32854613

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sevoflurane and Desflurane in people with Transplant; Failure, Kidney, run by Mahidol University at 1 site in Thailand.

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 4 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 15 Jun 2017. 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 Thailand. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Number of regulatory T cells (time frame: Within 24-h peri-operative period). 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 NCT02559297, which also lists 13 linked publications.

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 15 Jun 2017.

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