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

April 27, 2021 updated by: Elena Arnaoutoglou, University of Thessaly

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • Univeristy of Thessaly
        • Contact:
        • Principal Investigator:
          • Konstantinos Stamoulis, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DEXMEDETOMIDINE AND AKI
The patients of the group undergoing EVAR under general anesthesia will receive dexmedetomidine intraoperatively.
Drug: Dexmedetomidine
Administration of dexmedetomidine intraoperatively
No Intervention: CONTROL AND AKI
The patients of the group undergoing EVAR under general anesthesia will not receive dexmedetomidine intraoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Acute Kidney Injury
Time Frame: 1st Postoperative Day
Assess the incidence of Acute Kidney Injury after the administration of dexmedetomine
1st Postoperative Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative ICU admission
Time Frame: Operation day to 5th postoperative day
Record the incidence of unanticipated postoperative ICU admission
Operation day to 5th postoperative day
Incidence of arrhythmia
Time Frame: Up to 24 hours after surgery
Record the incidence of arrhythmia postoperatively
Up to 24 hours after surgery
Incidence of Postoperative Delirium
Time Frame: Operation day to 4th postoperative day
Record the incidence of Postoperative Delirium postoperatively
Operation day to 4th postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Investigators

  • Principal Investigator: Konstantinos Stamoulis, MD, PhD, University Hospital of Larissa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 30, 2021

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 20, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dexmedetomidine in EVAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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