Effects of Dexmedetomidine on Microcirculation of Kidney Transplant Recipient
Effects of Perioperative Dexmedetomidine Infusion on Microcirculation and Kidney and Intestinal Injury in Kidney Transplant Recipients
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2016
CompletedFirst Posted
Study publicly available on registry
March 14, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedDecember 17, 2020
April 1, 2020
2.7 years
March 9, 2016
December 13, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Total small vessel density of sublingual microcirculation
Sublingual microcirculation captured using an incident dark-field video microscope
Postoperative 2h
Creatinine level
Difference in serum creatine levels between the two groups
Postoperative day 2
Study Arms (2)
Control
NO INTERVENTIONRoutine anesthesia care for kidney transplant
Dexmedetomidine
EXPERIMENTALRoutine anesthesia care for kidney transplant and perioperative intravenous infusion of dexmedetomidine
Interventions
Eligibility Criteria
You may qualify if:
- kidney transplant recipient
You may not qualify if:
- allergic history to dexmedetomidine
- refractory bradycardia \< 60 bpm despite treatment
- severe atrioventricular block (2nd and 3rd degree)
- previous operation of tongue
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yu-Chang Yeh, PhD
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2016
First Posted
March 14, 2016
Study Start
August 1, 2016
Primary Completion
May 1, 2019
Study Completion
July 1, 2019
Last Updated
December 17, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share