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

Not Applicable

• Conditions: Kidney Transplantation
• Interventions: Drug: placebo; Drug: Dexmedetomidine

• Registration Number: NCT03327389
• Lead Sponsor: Yonsei University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-31
• Study Start: 2017-11-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-13
• Last Update Posted: 2019-01-15
• Primary Completion: 2019-09-28
• Study Completion: 2019-09-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (Group C)	placebo	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
Dexmedetomidine (Group D)	Dexmedetomidine	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

Primary Outcome Measures

Name	Time	Method
Serum creatinine level	postoperative 7 day

Secondary Outcome Measures

Name	Time	Method
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
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
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
incidence of delayed graft function	7 days 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
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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of