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

Primary Purpose

Kidney Transplantation

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Dexmedetomidine

placebo

About this trial

This is an interventional prevention trial for Kidney Transplantation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

adult (20-80 years old)
patients undergoing elective kidney transplantation

Exclusion Criteria:

emergency surgery
severe sinus bradycardia (<50 beats per min [bpm])
second-degree or third-degree heart block
decreased heart function (EF <30%)
acute myocardial ischemia
serious hepatic dysfunction (Child-Pugh class C)
patients with known or suspected severe adverse reactions to DEX (or clonidine)
treatment with clonidine or dexmedetomidine in the past 30 days

Sites / Locations

Department of Anesthesiology and Pain Medicine, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine (Group D)

Control (Group C)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Serum creatinine level

Secondary Outcome Measures

incidence of delayed graft function

level of serum creatinine

blood urea nitrogen (BUN)

cystatin C

Neutrophil gelatinase-associated lipocalin (NGAL)

urine output

fluid intake(intraoperative intake and output measured by the amount of fluid(crystalloid/colloid)(mL) and blood administered(mL))

kidney ultrasound

inflammatory mediator (IL-18, Il-1b) level

Full Information

NCT ID

NCT03327389

First Posted

October 23, 2017

Last Updated

January 13, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03327389

Brief Title

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

September 28, 2019 (Anticipated)

Study Completion Date

September 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Transplantation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Dexmedetomidine group Control group

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

participants, investicator, outcome assessors will be blinded for group allocation.

Allocation

Randomized

Enrollment

104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine (Group D)

Arm Type

Experimental

Arm Description

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

Arm Title

Control (Group C)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Intervention Description

dexmedetomidine was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

0.9% NaCl was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure

Primary Outcome Measure Information:

Title

Serum creatinine level

Time Frame

postoperative 7 day

Secondary Outcome Measure Information:

Title

incidence of delayed graft function

Time Frame

7 days after surgery

Title

level of serum creatinine

Time Frame

maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery

Title

blood urea nitrogen (BUN)

Time Frame

maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery

Title

cystatin C

Time Frame

maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery

Title

Neutrophil gelatinase-associated lipocalin (NGAL)

Time Frame

maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery

Title

urine output

Time Frame

during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery

Title

fluid intake(intraoperative intake and output measured by the amount of fluid(crystalloid/colloid)(mL) and blood administered(mL))

Time Frame

during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery

Title

kidney ultrasound

Time Frame

1 week, 1 month after surgery, if possible

Title

inflammatory mediator (IL-18, Il-1b) level

Time Frame

immediately after induction, immediately after vessel clamp, immediately after reperfusion, 1hour after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: adult (20-80 years old) patients undergoing elective kidney transplantation Exclusion Criteria: emergency surgery severe sinus bradycardia (<50 beats per min [bpm]) second-degree or third-degree heart block decreased heart function (EF <30%) acute myocardial ischemia serious hepatic dysfunction (Child-Pugh class C) patients with known or suspected severe adverse reactions to DEX (or clonidine) treatment with clonidine or dexmedetomidine in the past 30 days

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jin Ha Park, MD

Phone

82-2-2228-2420

Ext

82-2-2227-7897

realsummer@yuhs.ac

Facility Information:

Facility Name

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Ha Park, MD

Phone

82-2-2228-2420

Ext

82-2-2227-7897

realsummer@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34931289

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.

Results Reference

derived

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

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