Effects of Dexmedetomidine on Microcirculation of Kidney Transplant Recipient

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02707809
Collaborator
(none)
60
1
2
35
1.7

Study Details

Study Description

Brief Summary

The microcirculation is altered in acute kidney injury and chronic kidney disease. The microcirculation is poor in end-stage renal disease patients receiving hemodialysis. Kidney transplant can improve the life quality of these patients. However, surgical stress and inflammatory response may cause microcirculatory dysfunction and intestinal injury. Moreover, the transplanted kidney would suffer from the ischemia and reperfusion injury, and it may result in acute kidney injury. In ischemia and reperfusion injury animal model, dexmedetomidine has been proven to attenuate kidney and intestinal injury. In our previous study of surgical stress and pain stimulation rat model, we found that dexmedetomidine attenuate the intestinal microcirculatory dysfunction. In patients receiving coronary artery bypass graft surgery, dexmedetomidine increases urine output and decreases postoperative serum level of neutrophil gelatinase-associated lipocalin.

This study aims to investigate whether perioperative dexmedetomidine infusion may attenuate microcirculatory dysfunction, kidney injury, and intestinal injury for patients undergoing kidney transplant.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The microcirculation is altered in acute kidney injury and chronic kidney disease. The microcirculation is poor in end-stage renal disease patients receiving hemodialysis. Kidney transplant can improve the life quality of these patients. However, surgical stress and inflammatory response may cause microcirculatory dysfunction and intestinal injury. Moreover, the transplanted kidney would suffer from the ischemia and reperfusion injury, and it may result in acute kidney injury. In ischemia and reperfusion injury animal model, dexmedetomidine has been proven to attenuate kidney and intestinal injury. In our previous study of surgical stress and pain stimulation rat model, we found that dexmedetomidine attenuate the intestinal microcirculatory dysfunction. In patients receiving coronary artery bypass graft surgery, dexmedetomidine increases urine output and decreases postoperative serum level of neutrophil gelatinase-associated lipocalin. The aim of this study is to investigate whether perioperative dexmedetomidine infusion may attenuate microcirculatory dysfunction, kidney injury, and intestinal injury for patients undergoing kidney transplant.

This is a randomized, single-blind, prospective, controlled clinical trial. The patients will be randomly assigned to the control group or dexmedetomidine group. After induction of anesthesia, the patients in the control group will receive regular perioperative care. The patients in the dexmedetomidine group will receive perioperative dexmedetomidine continuous intravenous infusion after induction of anesthesia till 2 hours after the end of the operation. All patients will receive sublingual microcirculation examination, laboratory tests of blood urine nitrogen, creatinine, and enzyme-linked immunosorbent assays of serum level of endocan, diamine oxidase, and neutrophil gelatinase-associated lipocalin at preset time points. The urine level of neutrophil gelatinase-associated lipocalin will also be measured. The vital signs and urine output will be recorded. The difference between the two groups will be compared.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effects of Perioperative Dexmedetomidine Infusion on Microcirculation and Kidney and Intestinal Injury in Kidney Transplant Recipients
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Routine anesthesia care for kidney transplant

Experimental: Dexmedetomidine

Routine anesthesia care for kidney transplant and perioperative intravenous infusion of dexmedetomidine

Drug: Dexmedetomidine
Dexmedetomidine infusion
Other Names:
  • Precedex
  • Outcome Measures

    Primary Outcome Measures

    1. Total small vessel density of sublingual microcirculation [Postoperative 2h]

      Sublingual microcirculation captured using an incident dark-field video microscope

    2. Creatinine level [Postoperative day 2]

      Difference in serum creatine levels between the two groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • kidney transplant recipient
    Exclusion Criteria:
    • allergic history to dexmedetomidine

    • refractory bradycardia < 60 bpm despite treatment

    • severe atrioventricular block (2nd and 3rd degree)

    • previous operation of tongue

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Study Director: Yu-Chang Yeh, PhD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT02707809
    Other Study ID Numbers:
    • 201512039MINB
    First Posted:
    Mar 14, 2016
    Last Update Posted:
    Dec 17, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 17, 2020