The Effect of Dexmedetomidine on Kidney Function in EVAR

Acute Kidney Injury Clinical Trial

— DEVAR  

Official title:

The Effect of Dexmedetomidine on the Incidence of Acute Kidney Injury in EVAR

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04766047
• Other study ID #: Dexmedetomidine in EVAR
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: April 2021
• Source: University of Thessaly
• Contact: Eleni Arnaoutoglou, MD, PhD
• Phone: +306974301352
• Email: earnaout[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the effect of dexmedetomidine on the incidence of postoperative acute kidney injury in patients undergoing EVAR under general anesthesia

Description:

This study will compare the incidence of AKI after elective EVAR conducted under general anesthesia with and without administration of dexmedetomidine. The AKI will be evaluated through measuring NGAL and c-cystatin.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 1, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• elective EVAR under general anesthesia

• adult patients 18- 85 years old

• American society of anesthesiologists (ASA) physical status I - IV

Exclusion Criteria:

• refusal to participate or sign the informed consent form

• GFR < 50ml/mim

• Bradyarrhythmia <50/min

• Hemodynamic instability

• Known allergy to Dexmedetomidine

• Severe hepatic insufficiency

Related Conditions & MeSH terms

• Acute Kidney Injury
• Dexmedetomidine
• Endovascular Aortic Repair

Intervention

Drug:
• Dexmedetomidine
Administration of dexmedetomidine intraoperatively

Locations

Country	Name	City	State
Greece	Univeristy of Thessaly	Larissa	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Acute Kidney Injury	Assess the incidence of Acute Kidney Injury after the administration of dexmedetomine	1st Postoperative Day
Secondary	Incidence of postoperative ICU admission	Record the incidence of unanticipated postoperative ICU admission	Operation day to 5th postoperative day
Secondary	Incidence of arrhythmia	Record the incidence of arrhythmia postoperatively	Up to 24 hours after surgery
Secondary	Incidence of Postoperative Delirium	Record the incidence of Postoperative Delirium postoperatively	Operation day to 4th postoperative day