Kidney Transplantation
Conditions
Brief summary
The purpose of this study is to elucidate the effect of dexmedetomidine on renal function and delayed graft function after kidney transplantation
Interventions
DRUGDexmedetomidine
dexmedetomidine was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure.
DRUGplacebo
0.9% NaCl was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
participants, investicator, outcome assessors will be blinded for group allocation.
Intervention model description
1. Dexmedetomidine group 2. Control group
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. adult (20-80 years old) 2. patients undergoing elective kidney transplantation
Exclusion criteria
1. emergency surgery 2. severe sinus bradycardia (\<50 beats per min \[bpm\]) 3. second-degree or third-degree heart block 4. decreased heart function (EF \<30%) 5. acute myocardial ischemia 6. serious hepatic dysfunction (Child-Pugh class C) 7. patients with known or suspected severe adverse reactions to DEX (or clonidine) 8. treatment with clonidine or dexmedetomidine in the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum creatinine level | postoperative 7 day |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| incidence of delayed graft function | 7 days 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 |
| urine output | during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery |
Countries
South Korea
Contacts
Primary ContactJin Ha Park, MD
Outcome results
None listed