Effects of Dexmedetomidine on Postoperative Renal Function Recovery After Kidney Transplantation in Adult Patients

NCT ID: NCT02874378

Last Updated: 2017-01-20

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-12-31

Brief Summary

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Postoperative renal function recovery is very important to value the operation quality after kidney transplantation. Dexmedetomidine is a selective alpha-2 agonist,enhances urine flow rate and perioperative renal function. Some animal experiments have revealed its beneficial effects against ischemia-reperfusion injury (IRI), our goal is therefore to investigate the effectiveness of a recipient treatment with Dexmedetomidine during operation at reducing Cystatin C level and enhancing renal function after kidney transplantation.

Detailed Description

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Participants will be randomly assigned, in a 1:1 ratio, to receive Dexmedetomidine or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center.Dexmedetomidine and 0.9 %NaCl solution will be treated from 10 minutes before anesthesia induction, ending in the last 10 minutes before the operation to complete. Cystatin C level and urine volume (but are not limited to these data) at 1,7,14 days after the transplantation will be recorded. The participation of each patient is scheduled for 14 days.Investigators will research both living and cadaveric kidney transplants.

Conditions

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Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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study group

Dexmedetomidine will be pumped at 0.3μg/kg•h during the operation till 30 minutes before the operation complete. Standard anaesthesia and standard cure are given for all patients.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

control group

0.9%NaCl solution 0.1ml/kg•h during the operation till 30 minutes before the operation complete. Standard anaesthesia and standard cure are given for all patients.

Group Type PLACEBO_COMPARATOR

0.9%NaCl solution

Intervention Type DRUG

Interventions

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Dexmedetomidine

Intervention Type DRUG

0.9%NaCl solution

Intervention Type DRUG

Other Intervention Names

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Dexmedetomidine Injection normal saline

Eligibility Criteria

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Inclusion Criteria

Patients underwent renal transplant in the First Affiliated Hospital of Xi'an Jiaotong University.

Exclusion Criteria

severe comorbidity history: severe cardiac dysfunction, central nervous system disease, endocrine, and history of mental disorders; alcoholic and long-term use of sedatives and opioids history; drug allergy history.
Minimum Eligible Age

17 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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the 1st affiliated hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Xu, MD

Role: CONTACT

13772052823

Qiang Wang, PHD

Role: CONTACT

13991236768

Facility Contacts

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Jing Xu

Role: primary

014434670949

Other Identifiers

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XJTU1AFCT-2016-023

Identifier Type: -

Identifier Source: org_study_id

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