The Effect of Dexmedetomidine on Kidney Function in EVAR
DEVAR
1 other identifier
interventional
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2021
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedStudy Start
First participant enrolled
August 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedApril 28, 2021
April 1, 2021
2.3 years
February 2, 2021
April 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Acute Kidney Injury
Assess the incidence of Acute Kidney Injury after the administration of dexmedetomine
1st Postoperative Day
Secondary Outcomes (3)
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
Study Arms (2)
DEXMEDETOMIDINE AND AKI
ACTIVE COMPARATORThe patients of the group undergoing EVAR under general anesthesia will receive dexmedetomidine intraoperatively.
CONTROL AND AKI
NO INTERVENTIONThe patients of the group undergoing EVAR under general anesthesia will not receive dexmedetomidine intraoperatively.
Interventions
Eligibility Criteria
You may qualify if:
- elective EVAR under general anesthesia
- adult patients 18- 85 years old
- American society of anesthesiologists (ASA) physical status I - IV
You may not qualify if:
- refusal to participate or sign the informed consent form
- GFR \< 50ml/mim
- Bradyarrhythmia \<50/min
- Hemodynamic instability
- Known allergy to Dexmedetomidine
- Severe hepatic insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univeristy of Thessaly
Larissa, Thessaly, 41110, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eleni Arnaoutoglou, MD, PhD
University of Thessaly
- PRINCIPAL INVESTIGATOR
Konstantinos Stamoulis, MD, PhD
University Hospital of Larissa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of anesthesiology
Study Record Dates
First Submitted
February 2, 2021
First Posted
February 23, 2021
Study Start
August 30, 2021
Primary Completion
November 30, 2023
Study Completion
February 1, 2024
Last Updated
April 28, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share