The Effect of Dexmedetomidine on Kidney Function in EVAR

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

Sponsors

Lead Sponsor: University of Thessaly

Source University of Thessaly
Brief Summary

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

Detailed 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.

Overall Status Not yet recruiting
Start Date March 30, 2021
Completion Date February 1, 2024
Primary Completion Date November 30, 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of Acute Kidney Injury 1st Postoperative Day
Secondary Outcome
Measure Time Frame
Incidence of postoperative ICU admission Operation day to 5th postoperative day
Incidence of arrhythmia Up to 24 hours after surgery
Incidence of Postoperative Delirium Operation day to 4th postoperative day
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dexmedetomidine

Description: Administration of dexmedetomidine intraoperatively

Arm Group Label: DEXMEDETOMIDINE AND AKI

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Eleni Arnaoutoglou, MD, PhD

Phone: +306974301352

Email: [email protected]

Location
Facility: Contact: Contact Backup: Investigator: Univeristy of Thessaly Eleni Arnaoutoglou, MD, PhD 2413501370 [email protected] Eleni Arnaoutoglou, MD, PhD Principal Investigator Metaxia Bareka, MD, PhD Sub-Investigator Konstantinos Stamoulis, MD, PhD Principal Investigator
Location Countries

Greece

Verification Date

February 2021

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Thessaly

Investigator Full Name: Elena Arnaoutoglou

Investigator Title: Professor of anesthesiology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: DEXMEDETOMIDINE AND AKI

Type: Active Comparator

Description: The patients of the group undergoing EVAR under general anesthesia will receive dexmedetomidine intraoperatively.

Label: CONTROL AND AKI

Type: No Intervention

Description: The patients of the group undergoing EVAR under general anesthesia will not receive dexmedetomidine intraoperatively.

Acronym DEVAR
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov