DEVAR: The Effect of Dexmedetomidine on Kidney Function in EVAR

Sponsor

University of Thessaly (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04766047

Collaborator

(none)

200

Enrollment

Location

Arms

29.1

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Dexmedetomidine Endovascular Aortic Repair	Drug: Dexmedetomidine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 30, 2021

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of Acute Kidney Injury [1st Postoperative Day]
Assess the incidence of Acute Kidney Injury after the administration of dexmedetomine

Secondary Outcome Measures

Incidence of postoperative ICU admission [Operation day to 5th postoperative day]
Record the incidence of unanticipated postoperative ICU admission
Incidence of arrhythmia [Up to 24 hours after surgery]
Record the incidence of arrhythmia postoperatively
Incidence of Postoperative Delirium [Operation day to 4th postoperative day]
Record the incidence of Postoperative Delirium postoperatively

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univeristy of Thessaly	Larissa	Thessaly	Greece	41110

Sponsors and Collaborators

University of Thessaly

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elena Arnaoutoglou, Professor of anesthesiology, University of Thessaly

ClinicalTrials.gov Identifier:

NCT04766047

Other Study ID Numbers:

Dexmedetomidine in EVAR

First Posted:

Feb 23, 2021

Last Update Posted:

Apr 28, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elena Arnaoutoglou, Professor of anesthesiology, University of Thessaly

Acute kidney injury, Dexmedetomidine, EVAR

Additional relevant MeSH terms:

Acute Kidney Injury

Dexmedetomidine

Study Results

No Results Posted as of Apr 28, 2021