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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03327389
• Other study ID #: 4-2017-0767
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: September 28, 2019

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: Jin Ha Park, MD
• Phone: 82-2-2228-2420
• Email: realsummer[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: September 28, 2019
• Est. primary completion date: September 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed Graft Function
• Kidney Transplantation

Intervention

Drug:
• Dexmedetomidine
dexmedetomidine was infused at a rate of 0.4 µg/kg/h starting immediately after anesthetic induction and continued until skin closure.
• placebo
0.9% NaCl was infused at a rate of 0.4 µg/kg/h starting immediately after anesthetic induction and continued until skin closure

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatinine level		postoperative 7 day
Secondary	incidence of delayed graft function		7 days after surgery
Secondary	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
Secondary	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
Secondary	cystatin C		maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery
Secondary	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
Secondary	urine output		during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery
Secondary	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
Secondary	kidney ultrasound		1 week, 1 month after surgery, if possible
Secondary	inflammatory mediator (IL-18, Il-1b) level		immediately after induction, immediately after vessel clamp, immediately after reperfusion, 1hour after surgery