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

NCT ID: NCT03327389

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-09-28

Brief Summary

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

Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. Dexmedetomidine group
2. Control group
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
participants, investicator, outcome assessors will be blinded for group allocation.

Study Groups

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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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jin Ha Park, MD

Role: CONTACT

82-2-2228-2420 ext. 82-2-2227-7897

Facility Contacts

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Jin Ha Park, MD

Role: primary

82-2-2228-2420 ext. 82-2-2227-7897

References

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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.

Reference Type DERIVED
PMID: 34931289 (View on PubMed)

Other Identifiers

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4-2017-0767

Identifier Type: -

Identifier Source: org_study_id

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