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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Disease
• Intervention / Treatment: Drug: Dexmedetomidine

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimate): March 14, 2016

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 201512039MINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No