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Effects of Dexmedetomidine on Microcirculation of Kidney Transplant Recipient

Primary Purpose

Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Disease

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Dexmedetomidine

Arm Description

Routine anesthesia care for kidney transplant

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

Outcomes

Primary Outcome Measures

Total small vessel density of sublingual microcirculation
Sublingual microcirculation captured using an incident dark-field video microscope
Creatinine level
Difference in serum creatine levels between the two groups

Secondary Outcome Measures

Full Information

First Posted
March 9, 2016
Last Updated
December 13, 2020
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02707809
Brief Title
Effects of Dexmedetomidine on Microcirculation of Kidney Transplant Recipient
Official Title
Effects of Perioperative Dexmedetomidine Infusion on Microcirculation and Kidney and Intestinal Injury in Kidney Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine anesthesia care for kidney transplant
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Routine anesthesia care for kidney transplant and perioperative intravenous infusion of dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine infusion
Primary Outcome Measure Information:
Title
Total small vessel density of sublingual microcirculation
Description
Sublingual microcirculation captured using an incident dark-field video microscope
Time Frame
Postoperative 2h
Title
Creatinine level
Description
Difference in serum creatine levels between the two groups
Time Frame
Postoperative day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Chang Yeh, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Dexmedetomidine on Microcirculation of Kidney Transplant Recipient

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