Effect of Dexmedetomidine on Renal Function and Delayed Graft Function After Kidney Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to elucidate the effect of dexmedetomidine on renal function and delayed graft function after kidney transplantation

Official Title
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Effect of Dexmedetomidine on Renal Function and Delayed Graft Function After Kidney Transplantation

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult (20-80 years old) patients undergoing elective kidney transplantation Exclusion Criteria: emergency surgery severe sinus bradycardia (<50 beats per min [bpm]) second-degree or third-degree heart block decreased heart function (EF <30%) acute myocardial ischemia serious hepatic dysfunction (Child-Pugh class C) patients with known or suspected severe adverse reactions to DEX (or clonidine) treatment with clonidine or dexmedetomidine in the past 30 days

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dexmedetomidine group Control group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine (Group D)<br>Dexmedetomidine infusion during surgery Dexmedetomidine was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure | Drug: Dexmedetomidine<br>* dexmedetomidine was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure.<br>|
| Placebo Comparator: Control (Group C)<br>0.9% NaCl infusion during surgery 0.9% NaCl was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure | Drug: placebo<br>* 0.9% NaCl was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine level |  | postoperative 7 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of delayed graft function |  | 7 days after surgery | 
| level of serum creatinine |  | maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery | 
| blood urea nitrogen (BUN) |  | maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery | 
| cystatin C |  | maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery | 
| Neutrophil gelatinase-associated lipocalin (NGAL) |  | maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery | 
| urine output |  | during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery | 
| fluid intake(intraoperative intake and output measured by the amount of fluid(crystalloid/colloid)(mL) and blood administered(mL)) |  | during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery | 
| kidney ultrasound |  | 1 week, 1 month after surgery, if possible | 
| inflammatory mediator (IL-18, Il-1b) level |  | immediately after induction, immediately after vessel clamp, immediately after reperfusion, 1hour after surgery |