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

Primary Purpose

Renal Failure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
0.9%NaCl solution
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Failure

Eligibility Criteria

17 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the 1st affiliated hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study group

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cystatin C level

Secondary Outcome Measures

average daily urinary volume
length of hospital stay (LOS)
Wake up time, extubation time,SAS score,PONV
total dosage of remifentanil
Cr/GFR improvement

Full Information

First Posted
August 9, 2016
Last Updated
January 18, 2017
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT02874378
Brief Title
Effects of Dexmedetomidine on Postoperative Renal Function Recovery After Kidney Transplantation in Adult Patients
Official Title
Effects of Dexmedetomidine on Postoperative Renal Function Recovery After Kidney Transplantation in Adult Patients: Double-Blinded, Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexmedetomidine Injection
Intervention Type
Drug
Intervention Name(s)
0.9%NaCl solution
Other Intervention Name(s)
normal saline
Primary Outcome Measure Information:
Title
Cystatin C level
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
average daily urinary volume
Time Frame
2 weeks
Title
length of hospital stay (LOS)
Time Frame
an expected average of 2 weeks
Title
Wake up time, extubation time,SAS score,PONV
Time Frame
up to 6 hours
Title
total dosage of remifentanil
Time Frame
up to 4 hours
Title
Cr/GFR improvement
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Xu, MD
Phone
13772052823
Email
xuj0909@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Wang, PHD
Phone
13991236768
Email
dr.wangqiang@139.com
Facility Information:
Facility Name
the 1st affiliated hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Xu
Phone
014434670949
Email
xuj0909@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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