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

Renal Failure Clinical Trial

Official title:

Effects of Dexmedetomidine on Postoperative Renal Function Recovery After Kidney Transplantation in Adult Patients: Double-Blinded, Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02874378
• Other study ID #: XJTU1AFCT-2016-023
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2016
• Last updated: January 18, 2017
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Jing Xu, MD
• Phone: 13772052823
• Email: xuj0909[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• Dexmedetomidine

• 0.9%NaCl solution

Locations

Country	Name	City	State
China	the 1st affiliated hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cystatin C level		2 weeks
Secondary	average daily urinary volume		2 weeks
Secondary	length of hospital stay (LOS)		an expected average of 2 weeks
Secondary	Wake up time, extubation time,SAS score,PONV		up to 6 hours
Secondary	total dosage of remifentanil		up to 4 hours
Secondary	Cr/GFR improvement		2 weeks