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

NCT02874378 | Unknown DMC

• 1 other identifier: XJTU1AFCT-2016-023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

• Cystatin C level

  2 weeks

Secondary Outcomes (5)

• average daily urinary volume

  2 weeks

• length of hospital stay (LOS)

  an expected average of 2 weeks

• Wake up time, extubation time,SAS score,PONV

  up to 6 hours

• total dosage of remifentanil

  up to 4 hours

• Cr/GFR improvement

  2 weeks

Study Arms (2)

study group

EXPERIMENTAL

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.

Drug: Dexmedetomidine

control group

PLACEBO COMPARATOR

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.

Drug: 0.9%NaCl solution

Interventions

Dexmedetomidine DRUG

Also known as: Dexmedetomidine Injection

study group

0.9%NaCl solution DRUG

Also known as: normal saline

control group

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

the 1st affiliated hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Jing Xu, MD

CONTACT

13772052823; xuj0909@163.com

Qiang Wang, PHD

CONTACT

13991236768; dr.wangqiang@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 22, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

CN (1)