Clinical trial NCT03327389: Effect of Dexmedetomidine on Renal Function and Delayed Graft Function After Kidney Transplantation
Official title: Effect of Dexmedetomidine on Renal Function and Delayed Graft Function After Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplantation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Dexmedetomidine group
2. Control group
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Serum creatinine level
timeFrame: postoperative 7 day
Secondary outcomes:
measure: incidence of delayed graft function
timeFrame: 7 days after surgery
measure: level of serum creatinine
timeFrame: maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery
measure: blood urea nitrogen (BUN)
timeFrame: maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery
measure: cystatin C
timeFrame: maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery
measure: Neutrophil gelatinase-associated lipocalin (NGAL)
timeFrame: maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery
measure: urine output
timeFrame: during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery
measure: fluid intake(intraoperative intake and output measured by the amount of fluid(crystalloid/colloid)(mL) and blood administered(mL))
timeFrame: during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery
measure: kidney ultrasound
timeFrame: 1 week, 1 month after surgery, if possible
measure: inflammatory mediator (IL-18, Il-1b) level
timeFrame: immediately after induction, immediately after vessel clamp, immediately after reperfusion, 1hour after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Park JH, Koo BN, Kim MS, Shin D, Kwak YL. Effects of intraoperative dexmedetomidine infusion on renal function in elective living donor kidney transplantation: a randomized controlled trial. Can J Anaesth. 2022 Apr;69(4):448-459. doi: 10.1007/s12630-021-02173-1. Epub 2021 Dec 20.