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The Effect of Dexmedetomidine on Kidney Function in EVAR (DEVAR)

Primary Purpose

Acute Kidney Injury, Dexmedetomidine, Endovascular Aortic Repair

Status
Not yet recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring Acute kidney injury, Dexmedetomidine, EVAR

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univeristy of Thessaly

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

DEXMEDETOMIDINE AND AKI

CONTROL AND AKI

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of Acute Kidney Injury
Assess the incidence of Acute Kidney Injury after the administration of dexmedetomine

Secondary Outcome Measures

Incidence of postoperative ICU admission
Record the incidence of unanticipated postoperative ICU admission
Incidence of arrhythmia
Record the incidence of arrhythmia postoperatively
Incidence of Postoperative Delirium
Record the incidence of Postoperative Delirium postoperatively

Full Information

First Posted
February 2, 2021
Last Updated
April 27, 2021
Sponsor
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT04766047
Brief Title
The Effect of Dexmedetomidine on Kidney Function in EVAR
Acronym
DEVAR
Official Title
The Effect of Dexmedetomidine on the Incidence of Acute Kidney Injury in EVAR
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 30, 2021 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Dexmedetomidine, Endovascular Aortic Repair
Keywords
Acute kidney injury, Dexmedetomidine, EVAR

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DEXMEDETOMIDINE AND AKI
Arm Type
Active Comparator
Arm Description
The patients of the group undergoing EVAR under general anesthesia will receive dexmedetomidine intraoperatively.
Arm Title
CONTROL AND AKI
Arm Type
No Intervention
Arm Description
The patients of the group undergoing EVAR under general anesthesia will not receive dexmedetomidine intraoperatively.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Administration of dexmedetomidine intraoperatively
Primary Outcome Measure Information:
Title
Incidence of Acute Kidney Injury
Description
Assess the incidence of Acute Kidney Injury after the administration of dexmedetomine
Time Frame
1st Postoperative Day
Secondary Outcome Measure Information:
Title
Incidence of postoperative ICU admission
Description
Record the incidence of unanticipated postoperative ICU admission
Time Frame
Operation day to 5th postoperative day
Title
Incidence of arrhythmia
Description
Record the incidence of arrhythmia postoperatively
Time Frame
Up to 24 hours after surgery
Title
Incidence of Postoperative Delirium
Description
Record the incidence of Postoperative Delirium postoperatively
Time Frame
Operation day to 4th postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eleni Arnaoutoglou, MD, PhD
Phone
+306974301352
Email
earnaout@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantinos Stamoulis, MD, PhD
Phone
+306973335073
Email
kosta171970@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleni Arnaoutoglou, MD, PhD
Organizational Affiliation
University of Thessaly
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Konstantinos Stamoulis, MD, PhD
Organizational Affiliation
University Hospital of Larissa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Thessaly
City
Larissa
State/Province
Thessaly
ZIP/Postal Code
41110
Country
Greece
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleni Arnaoutoglou, MD, PhD
Phone
2413501370
Email
earnaout@gmail.com
First Name & Middle Initial & Last Name & Degree
Konstantinos Stamoulis, MD, PhD
Phone
+306973335073
Email
kosta171970@icloud.com
First Name & Middle Initial & Last Name & Degree
Eleni Arnaoutoglou, MD, PhD
First Name & Middle Initial & Last Name & Degree
Metaxia Bareka, MD, PhD
First Name & Middle Initial & Last Name & Degree
Konstantinos Stamoulis, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Dexmedetomidine on Kidney Function in EVAR

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