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Effects of Dexmedetomidine on Microcirculation of Kidney Transplant Recipient

NCT ID: NCT02707809

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Routine anesthesia care for kidney transplant

Group Type NO_INTERVENTION

No interventions assigned to this group

Dexmedetomidine

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine infusion

Interventions

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Dexmedetomidine

Dexmedetomidine infusion

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Chang Yeh, PhD

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201512039MINB

Identifier Type: -

Identifier Source: org_study_id