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

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

Study Overview

• Status: Unknown
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
    • Contact: Jin Ha Park, MD; Phone Number: 82-2-2227-7897 82-2-2228-2420; Email: realsummer@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine (Group D); 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; dexmedetomidine was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure.
Placebo Comparator: Control (Group C); 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; 0.9% NaCl was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum creatinine level	postoperative 7 day

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): September 28, 2019
• Study Completion (Anticipated): September 28, 2019

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Delayed Graft Function; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 4-2017-0767

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No