The Effect of Dexmedetomidine on Kidney Function in EVAR | NCT04766047

Studies
The Effect of Dexmedetomidine on Kidney Function in EVAR

NCT04766047

Sponsor

University of Thessaly

Status

Unknown status

Last Update Posted

Apr 28, 2021Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Acute Kidney Injury
Dexmedetomidine
Endovascular Aortic Repair

Interventions

Dexmedetomidine

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2021Estimated

Primary Completion Date

Nov 30, 2023Estimated

Completion Date

Feb 1, 2024Estimated

First Submitted Date

Feb 2, 2021

First Submission Date that Met QC Criteria

Feb 20, 2021

First Posted Date

Feb 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2021

Last Update Posted Date

Apr 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elena Arnaoutoglou, Professor of anesthesiology, University of ThessalyPrincipal Investigator

Lead Sponsor

University of ThessalyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DEXMEDETOMIDINE AND AKI	Active Comparator	The patients of the group undergoing EVAR under general anesthesia will receive dexmedetomidine intraoperatively.	Drug: Dexmedetomidine
CONTROL AND AKI	No Intervention	The patients of the group undergoing EVAR under general anesthesia will not receive dexmedetomidine intraoperatively.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	Administration of dexmedetomidine intraoperatively	DEXMEDETOMIDINE AND AKI

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Incidence of postoperative ICU admission	Record the incidence of unanticipated postoperative ICU admission	Operation day to 5th postoperative day
Incidence of arrhythmia	Record the incidence of arrhythmia postoperatively

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eleni Arnaoutoglou, MD, PhD	Contact	+306974301352		earnaout@gmail.com
Konstantinos Stamoulis, MD, PhD	Contact	+306973335073		kosta171970@icloud.com

Overall Officials

Name	Affiliation	Role
Eleni Arnaoutoglou, MD, PhD	University of Thessaly	Study Chair
Konstantinos Stamoulis, MD, PhD	University Hospital of Larissa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univeristy of Thessaly		Larissa	Thessaly	41110	Greece

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided