NCT03327389

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

1.9 years

First QC Date

October 23, 2017

Last Update Submit

January 13, 2019

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Serum creatinine level

    postoperative 7 day

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Dexmedetomidine (Group D)

EXPERIMENTAL

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

Control (Group C)

PLACEBO COMPARATOR

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

Interventions

DexmedetomidineDRUG

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

Dexmedetomidine (Group D)
placeboDRUG

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

Control (Group C)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 03722, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34931289DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Jin Ha Park, MD

CONTACT

82-2-2228-2420realsummer@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
participants, investicator, outcome assessors will be blinded for group allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1. Dexmedetomidine group 2. Control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 31, 2017

Study Start

November 1, 2017

Primary Completion

September 28, 2019

Study Completion

September 28, 2019

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)