The Effect of Dexmedetomidine on Kidney Function in EVAR

NCT ID: NCT04766047

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2024-02-01

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury Dexmedetomidine Endovascular Aortic Repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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DEXMEDETOMIDINE AND AKI

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Administration of dexmedetomidine intraoperatively

CONTROL AND AKI

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexmedetomidine

Administration of dexmedetomidine intraoperatively

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Elena Arnaoutoglou

Professor of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eleni Arnaoutoglou, MD, PhD

Role: STUDY_CHAIR

University of Thessaly

Konstantinos Stamoulis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Larissa

Locations

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Univeristy of Thessaly

Larissa, Thessaly, Greece

Site Status

Countries

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Greece

Central Contacts

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Eleni Arnaoutoglou, MD, PhD

Role: CONTACT

+306974301352

Konstantinos Stamoulis, MD, PhD

Role: CONTACT

+306973335073

Facility Contacts

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Eleni Arnaoutoglou, MD, PhD

Role: primary

2413501370

Konstantinos Stamoulis, MD, PhD

Role: backup

+306973335073

Other Identifiers

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Dexmedetomidine in EVAR

Identifier Type: -

Identifier Source: org_study_id

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